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CDISC Collaborative Culture in Action - The CDISC Winter Intrachange

March 21, 2014 at 9:55 AM by cdisc

The 2014 CDISC Winter Intrachange was held February 25th – 27th in Silver Spring, Maryland. CDISC Intrachanges are informal CDISC cross-team meetings for CDISC standards development teams, as opposed to Interchanges, which are yearly conferences, focused on presentations and the sharing of implementation approaches and experience.

 

Katzenbach and Smith (2008) define a team as, “a small number of people with complementary skills who are committed to a common purpose, set of performance goals, and approaches for which they hold themselves mutually accountable.”

 

Photo by Rhonda Facile

 


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SHARE R1 is Done

February 13, 2014 at 4:41 PM by cdisc

SHARE is no longer merely a vision, idea, or plan. After nearly 6 months of implementation work SHARE R1, our first production library, has been completed. Woot woot! This is a major milestone. We've taken the first step on a long journey towards realizing the vision of transforming the CDISC standards into an end-to-end, interoperable set of metadata all available in a machine-readable format.

 

Both SDTM 1.2 (IG 3.1.2) and CDASH 1.1 have both been loaded into the production SHARE Library. Using SHARE R1 we will load SDTM 1.3 (IG 3.1.3) and SDTM 1.4 (IG 3.2) in the coming weeks. Although the CDISC Controlled Terminology development and governance processes will remain unchanged, we will continue to load each newly released terminology package into SHARE. BRIDG 3.2 and the ISO 20190 data types have also been loaded into the R1 library.


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FDA Guidance on Standardized Study Data for Electronic Submissions

February 6, 2014 at 6:00 PM by cdisc

 

Today, 6 February 2014, the U.S. Food and Drug Administration officially published several guidances for electronic regulatory submissions to the FDA. The documents, linked below, are a package for industry that include information on FDASIA, eStudy, a Conformance Guide and Standards Catalog, and have a 90-day window for public comment.

 

The Study Data Technical Conformance Guide was developed in an effort to combine the existing Common Issues, Study Data Specifications and Traceability Guidance documents, as well as Validation Rules, in order to offer one technical document that coordinates all these sources for the industry. The Standardized Study Data guidance provides requirements for a valid electronic submission of standardized study data to the FDA, including format specifications.

 

FDA-2014-D-0092 - Study Data Technical Conformance Guide and Data Standards Catalog

FDA-2012-D-0097 - Guidance on Electronic Submissions: Standardized Study Data

FDA-2014-D-0085 - Guidance on Submissions in Electronic Format--Submissions under the Federal Food, Drug, and Cosmetic Act


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World Cancer Day 2014

February 4, 2014 at 5:15 PM by cdisc

While the news on World Cancer Day has focused on the illusive cure to cancer, I would like to shed some light and bring necessary attention to one of the main ways that we as a global society of patients can actually work to ensure the faster development of therapies: the implementation and utilization of clinical research standards.

 

On this day, World Cancer Day 2014, we would like to pause to thank our volunteers, whose tireless efforts developing standards for clinical research are working toward real change to shorten the drug development timeline, bringing new and more effective therapies to patients more quickl


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Metadata Curator Wanted

December 18, 2013 at 12:16 PM by cdisc

Being a metadata curator means most won’t exactly understand what you do. You can certainly forget about explaining your job to your mom. Traditionally, curators have managed collections of old stuff, like what you might find in a museum. In today’s world of informatics and big data, however, metadata curators play an essential role in enabling metadata driven automation and semantic interoperability.

 

At CDISC we are implementing the SHARE metadata repository to manage the latest standards metadata, as well as the older stuff. The SHARE metadata curators will play a critical role in defining and administrating the processes and policies for governing the metadata that will become the CDISC standards. They will help to lead the CDISC community towards new ways of standards development. In this capacity, the metadata curator must be a passionate advocate for clinical research data standards, a strong communicator, as well as an energetic collaborator. Since SHARE represents a new approach to standards development, creative chops are a must.


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What’s new with SDTMIG v3.2?

December 16, 2013 at 1:42 PM by cdisc

 

The recently-released SDTMIG v3.2 includes many enhancements and improvements from earlier versions. During development and the Public Review, the document had been identified as SDTMIG v3.1.4. However, given the broad scope and significance of the changes incorporated in the update, and the move toward consistency in how all CDISC standard versions are numbered, a decision was made to release this SDTMIG as Version 3.2 instead of v3.1.4.

 

This decision means that the relationship between and SDTMIG and its corresponding SDTM version won’t be apparent from the SDTMIG version number any longer. In reality, the perceived synchronicity between SDTM and SDTMIG version numbers was never intentional, though conveniently coincidental up until now. The SDTM and SDTMIG were always meant to be independent documents versioned independently. This was always the case for other IGs based on the SDTM, such as SEND and the more recent Medical Devices and Associated Persons IGs. With this release of the new SDTM and SDTMIG, independence of SDTM and IG version numbers now applies to the SDTMIG for Human Clinical Trials as well.


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Learning Health Community – ESTEL Meeting hosted by Duke

October 21, 2013 at 1:13 PM by cdisc

On 16-17 September 2013, the Duke Center for Health Informatics (DCHI) hosted a two-day meeting for high-level strategy discussions pertaining to the Essential Standards to Enable Learning (ESTEL) initiative of the Learning Health Community. This was the third face-to-face meeting focused on the ESTEL initiative, led by the Clinical Data Interchange Standards Consortium (CDISC). Participants from universities, clinical research organizations, biopharmaceutical companies, technology companies, service providers, standards-developing organizations and related healthcare entities travelled from as far away as the United Kingdom and California and also included a number of prominent organizations from Duke's backyard such as North Carolina Health Information and Communications Alliance, Inc. (NCHICA), SAS, GlaxoSmithKline and Quintiles. The multi-stakeholder participants, who share a dedication to collaboratively realizing a national-scale Learning Health System (LHS), worked together over the two days to build consensus on a framework for identifying and developing an essential set of standards to empower stakeholders across the healthcare and health IT spectra to realize the LHS vision. Collaborative work included reviewing current learning projects and identifying standards-related lessons learnable from them; identifying potential barriers to success and corresponding ways to surmount them; further developing a scope for the ESTEL initiative; and strategizing around next steps culminating in concrete actions promising to make meaningful impacts.


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FDA Announces Intent to Require CDISC Standards

September 26, 2013 at 3:50 AM by cdisc

In July 2004, FDA Commissioner Lester M. Crawford, FDA Commissioner announced the desire of the FDA to receive data in a standard format, the CDISC SDTM. "The importance of a standard for the exchange of clinical trial data cannot be overstated," said Dr. Crawford, "FDA reviewers spend far too much valuable time simply reorganizing large amounts of data submitted in varying formats. Having the data presented in a standard structure will improve FDA's ability to evaluate the data and help speed new discoveries to the public.”

 

While this was a very welcome message and encouraged many companies to begin to become more interested in CDISC standards, it hardly produced a sudden groundswell in the adoption of CDISC data standards among sponsors.


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What Did the CDISC Teams Accomplish during the Recent CDISC INTRAchange in Silver Spring, MD?

August 29, 2013 at 3:50 PM by cdisc

What Did the CDISC Teams Accomplish during the Recent CDISC INTRAchange in Silver Spring, MD?

 

The CDISC INTRAchange is an opportunity for CDISC team members to meet and discuss their CDISC-related work, including current and future tasks, and it provides a special opportunity for cross-team meetings to ensure an understanding of how one team’s activities relate to others. Team members are volunteers who dedicate time from their busy schedules to develop CDISC standards for the purpose of achieving the CDISC mission to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare. The CDISC teams are essential to the progress of CDISC and to the process of developing consensus-based global standards. All of the CDISC teams met at the INTRAchange during this 3-day period at the end of July and 1 August. To find out more about the specific CDISC Teams and deliverables, please see the CDISC Annual Report 2012.

 

The event started on the morning of 30 July with the opening plenary by Wayne Kubick, CDISC CTO, who expressed his deep appreciation to the CDISC volunteers for their hard work and essential role in achieving the CDISC mission. He also presented the CDISC Technical Roadmap and updated all attendees. Dr. Ron Fitzmartin of FDA then presented the FDA Standards Strategy. The slides from these presentations can be made available upon request.

 

 

 

 

 

 

 

 

 

 

 


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Standards and Changing Global Demographics

July 24, 2013 at 1:41 PM by cdisc

During my time abroad I was able to combine my most recent coursework—Western European Politics—with everything I learned about medical research standards on the trip. Specifically, in meetings with CDISC in both France and the U.K., I noticed similarities and differences between approaches to standards and markets. Regardless, as the majority of populations in countries become older, it is increasingly more difficult to maintain a prosperous welfare state. A welfare state is generally described as a country that provides assistance for citizens in need to buffer them from the negative consequences of age, unemployment, poverty and illness. In order to preserve the welfare state to which many citizens have become accustomed, it is imperative that European countries use information more efficiently; standards can play a key role, in this respect, in the area of medical research information.

 

As the populations in European countries age and governments must become increasingly sensitive to this, the need for standards in the European market will be imperative. Standards not only provide a way to get an accurate representation of the make-up of some of the most historically homogenized cultures, but they open up a broad market for researching and developing data and metadata to more appropriately serve the aging demographic of people in these countries. They can also help to address increasing diversity; in other words, to add complexity to the situation, the movement of individuals from country to country also affects the demographics of the population within and across European countries.


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CDISC in Europe – June 2013

July 24, 2013 at 6:43 PM by cdisc

We had the pleasure of meeting with a number of wonderful individuals in Europe in June. The theme from our perspective was CDISC, of course, but there were many threads of conversation that wove together a lovely tapestry of memory from this particular trip and, in turn, we feel was extremely helpful to CDISC.

 

The trip began in Paris, meeting with Dr. Michel Goldman and Dr. Olivier Arnaud. The topic was around the Juvenile Diabetes Research Foundation, for which Dr. Arnaud is providing scientific expertise in Europe. Dr. Goldman is an amazing individual who leads the Innovative Medicines Initiative. He had expert advice to lend during this meeting for the JDRF in Europe. CDISC has just launched a diabetes therapeutic area standards project and IMI has projects in diabetes, so a relationship is attractive to all of the organizations and the value of having standards for diabetes research is clear. On a recent call of the CFAST Scientific Advisory Committee, one attendee remarked of the data sharing initiative we were discussing: “The data are so much more valuable when they are in a common standard format”.



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FDA Data Standards Strategy DIA Session, Wednesday, 26 June 13

July 24, 2013 at 6:53 PM by cdisc

I did not attend many sessions at the DIA meeting because, as many attendees, I was busy meeting new people interested in CDISC and reconnecting with many old friends. I did, however, chair one session – on CFAST: Coalition For Accelerating Standards and Therapies and I attended the subsequent session chaired by Dr. Steve Wilson on the FDA Data Standards Strategy. This was a very informative session with three speakers and a ‘commenter’: Dr. Ron Fitzmartin (FDA), Bron Kisler (CDISC), Mitra Rocca (FDA) and Michael Brennan (J&J).

 

Dr. Fitzmartin spoke of FDASIA, the FDA Safety and Innovation Act. Specifically, Section 1136 allows FDA to require standardized eSubmissions. Also, it reauthorizes the fifth instance of the Prescription Drug User Fee Act (PDUFA V). The schedule for phasing in these eSubmission requirements is specified as 24 or 36 months after publication of the final guidance (time frame depending on the type of submission). Section XII under the PDUFA Goals states the following:

 

  • Clinical Terminology Standards: Using a public process that allows for stakeholder input, FDA shall develop standardized clinical data terminology through open standards organizations (i.e., CDISC)…

 

Also, FDA is to publish a proposed project plan for stakeholder review and comment by 30 June 2013. Dr. Fitzmartin stated that this TA Standards Project Plan is in Clearance at FDA, along with the eStudy Data Guidance and an eSource Guidance. He provided further specifics around the FDA Path to Required Study Data Standards.


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CDISC User Networks

June 19, 2013 at 6:18 PM by cdisc

The CDISC User Networks are volunteer-initiated and volunteer-led. The CDISC Bay Area User Network was the first among the current ~ 20 of such networks, having been formed over a decade ago by John Brega. I had the privilege of attending their most recent meeting, which attracted close to 100 attendees in person and another 50+ via phone. I will write separately with a report on additional details from this meeting, which was kindly sponsored by Formedix.

 

Now, for this blog, I want to focus on the CDISC User Networks in general, since there has been much interest and discussion on the topic this year among CDISC stakeholders, Operations staff and, in particular, the European CDISC Coordinating Committee (E3C). It seems there are opportunities with respect to the User Networks that we could better capture for the benefit of all our CDISC supporters, and there is related interest from our stakeholders in reaping the fruits of these opportunities. For this reason, CDISC has committed to reach out to the leadership of each of the User Networks to see how we could further support their efforts and how we can do a better job of listening to the valuable input that they offer to CDISC.


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CDISC Bay Area User Network

June 19, 2013 at 10:28 PM by cdisc

 

The Bay Area CDISC User Network met on 23 May, thanks to Formedix for sponsoring a venue and John Brega (founder and leader of this User Network) for organizing the excellent turnout of CDISC supporters and interested parties from northern California. There were nearly 100 attendees in person and over 50 on the teleconference at this event, which followed a Formedix breakfast meeting targeted to management. The venue was the South San Francisco Conference Center, which is an award-winning building (for being green) that is conveniently located within a few miles of the San Francisco airport and numerous biotechnology companies that have sprung up over the years near Genentech.

 

The morning program was quite interesting to me. I heard Mark Wheeldon speak about his 13-year history and experience with CDISC standards, and David Borbas of Jazz Pharmaceuticals gave a business case for management on the use of CDISC and Define tools such as those that Formedix offers. (I spoke about the CDISC strategy and technical roadmap). We (CDISC Communications) featured a Formedix success story a few months ago and will be featuring the Jazz story from Mr. Borbas in the near future. The slides from all of these presentations are in the CDISC User Network portal, posted by John Brega. These are examples of how CDISC User Networks can share relevant interesting information among anyone interested and make it available around the globe.


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Notes from Partnerships in Clinical Trials

May 14, 2013 at 6:41 PM by cdisc

 

While most of the CDISC staff were in Europe supporting the 2013 Europe Interchange, Sheila Leaman (CDISC Director of Global Relations) and I went to Orlando for the 2013 Partnerships in Clinical Trials conference. At the conference, we met with current CDISC members, handing out “Proud to be a CDISC Member” signs for their booths and engaging with them to gain information on their experiences with CDISC. We also had the opportunity to liaise with potential members to convey the benefits of membership and answer any questions they might have. In all, this was a fantastic experience, and personally having the occasion to meet face to face with those that utilize and support CDISC standards development was tremendously rewarding.

 

In addition to meeting with current and potential members, we took the time to sit in on one of the discussions, “The Evolution of Clinical Trial Partnerships – Initiative to Forge Innovative Collaborations across the Entire Healthcare Chain.” Speakers during this session were Kathleen Ford of Merck Serono, Ed Pezalla of Aetna, Christine Dingivan of PPD, Kelly Davis of Express Scripts and Dalvir Gill of TransCelerate Biopharma. Sheila and I had had the opportunity to have a very successful discussion with Dr. Gill earlier in the day about the collaboration between CDISC and TransCelerate Biopharma in the area of Therapeutic Area Standards development, and were excited to hear him speak on the panel during this session.


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CDISC Europe Interchange 2013 - Very Pleasant Start

May 14, 2013 at 7:01 PM by cdisc

CDISC Europe Interchange 2013 started with very pleasant weather in Germany--- the beginning of the spring season! Our attendees enjoyed the beautiful location in the heart of Bad Nauheim (a lovely small town north of Frankfurt where Elvis Presley spent two years of his life), and the special event of the 10th CDISC European Interchange this year!

 

 

 

As for previous CDISC Interchanges, the CDISC team spent the prior weekend on final preparations, making sure to keep the conference running smoothly and efficiently while providing the best possible support to our attendees.


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A Flavor of the CDISC Europe Interchange

May 14, 2013 at 7:14 PM by cdisc

 

Each year for the past 10 years, the European CDISC Coordinating Committee (E3C) has organized a CDISC Interchange. This year’s was touted as the best Interchange held in the last 5 years by many long-time attendees, and was highly regarded by those who have not had the opportunity to attend the earlier Interchanges. The success can be attributed to a program of interest to everyone, excellent keynote speakers and panel discussions that allowed the opportunity for all to participate. The venue should also be noted – many thanks to Dominik Ruisinger, who selected a comfortable hotel with a large conference area in an absolutely lovely area in Bad Nauheim, Germany, near Frankfurt. Spring was in the air and the trees and flowers were blooming in the park that surrounded this hotel. When I arrived in Frankfurt and was en route to the hotel, I was told by one of the locals that “Bad” in front of a town name in Germany means you should go there to relax. I commented that perhaps I could relax after our meetings with the E3C, the CDISC Advisory Council and the Interchange, and how I wish I had taken a day of vacation at the end of the week to do just that!

 

The atmosphere at the Interchange was anything but what I would call relaxing. It was stimulating, enjoyable, educational, informative and very productive. The attendees and exhibitors had great ideas for CDISC, from how to better engage the User Networks and additional projects that the E3C would like to achieve this year, to excellent suggestions from the CDISC Advisory Council members or their alternates in Europe on how they could be more effective in assisting and advising CDISC. , to the Interchange itself. This blog merely seeks to give one a flavor of the Interchange – one really had to be there to experience it appropriately! Mark your calendars for next year: 7-11 April 2014 in Paris, and don’t forget that we have one in Bethesda, MD on 4-8 November 2013, for which we are currently inviting speakers and calling for abstracts!


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The Tenth CDISC European Interchange - An Outstanding Experience

May 14, 2013 at 7:48 PM by cdisc

Attending the CDISC European Interchange this year was a unique and very successful experience. Many attendees declared that this event was one of the best CDISC European Interchanges that they have attended throughout the past 10 years. CDISC celebrated the anniversary of the 10th European Interchange this year in Bad Nauheim, Germany.

 

We had a great exhibition area in which our exhibitors, presenters and attendees met and communicated about recent accomplishments, including tools and service providers that support CDISC standards.

 

 

“With the power of our volunteers, CDISC has developed additional standards in the past 4 years including therapeutic area standards. We have been listening to your input on how we can provide additional value to CDISC stakeholders. We enhanced collaboration and education and are providing a Protocol Representation Tool and others are coming. Patients are waiting for therapies and their time is precious! We need to make sure that they understand the value of data standards”, Dr. Kush, President and CEO of CDISC stated at the opening session of the CDISC European Interchange in April in Germany. Dr. Kush also mentioned that CDISC standards are cited in the Structured Data Capture (SDC) Initiative of the U.S. Health and Human Services Office of the National Coordinator of Health IT, which offers incentives for meaningful use of electronic health records. And, CDISC has endorsed the movement of the Learning Health System (LHS) and is now leading the Essential Standards to Enable Learning (ESTEL) Initiative while participating in Europe in the IMI EHR4CR project. Communication is key, she stated at the end of her State of the CDISC Union presentation.

 


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Healthcare and Research: A Venn Situation

April 17, 2013 at 9:00 PM by cdisc

 

Recent discussions concerning the Learning Health System (LHS), and particularly Essential Standards to Enable Learning (ESTEL), have exposed varying perspectives on the relative overlap standards should have between healthcare and research. There are those who feel research and healthcare have quite different standards requirements while, on the other end of the spectrum, there are those who believe that standards for both research and healthcare should be exactly the same. Of course, there are still others who will indicate that it depends on the type of standards being referenced. Sixteen years after Bron Kisler and I developed a slide with two intersecting circles – one for healthcare and one for research – I am even more convinced that this is a Venn situation.

 

From Wikipedia: A Venn diagram or set diagram is a diagram that shows all possible logical relations between a finite collection of sets (aggregation of things). Venn diagrams were conceived around 1880 by John Venn. They are used to teach elementary set theory, as well as illustrate simple set relationships in probability, logic, statistics, linguistics and computer science (see logical connectives).

 

Below is the slide I am referencing, which was our vision in 1997 as to how to streamline research.

 

 


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The CDISC Vision, Harmony, Chaords and a Learning Health Community

March 12, 2013 at 4:17 PM by cdisc

The CDISC vision is informing patient care and safety through higher quality medical research. This might be viewed as the CDISC contribution to a ‘Learning Health System’. When CDISC was founded in 1997, there was (and still is) a clear desire to streamline the means by which research information can be gleaned from clinical care to ultimately provide increasingly better knowledge to benefit patients. This desire was communicated as two key goals: 1) to make it easier for clinicians to do research, and 2) to improve data quality and patient safety.

 

You have heard this before, but we are all patients; and, those of us who have been working with CDISC for the past 1.5 decades are that much older and feeling an increased urgency towards accelerating the ‘research-healthcare learning cycle’. The 17 years that it is said to take for research findings to make their way back into clinical care decisions is simply too long, and we all know that healthcare costs continue to skyrocket without the resultant improvement in speed of innovation nor quality of care.


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Great Moments at the CDISC Asia-Pacific Interchange

March 11, 2013 at 10:26 AM by cdisc

Great Moments at the CDISC Asia-Pacific Interchange The Inaugural CDISC Asia-Pacific Interchange (CAPI), held in Singapore 18-22 February, was an incredibly successful event, drawing over 100 leaders from Thailand, India, Japan, Singapore, South Korea, China, and Australia, as well as the USA, France, the UK and Belgium. While conference content included traditional subjects, such as presentations on case studies using and implementing the CDISC standards, there were also heavily attended and engaging subjects specialized for the Asia-Pacific region. Specifically, there were updates on the status of clinical research and usage of CDISC standards around the Asia-Pacific region, region-specific presentations on the use of EHRs for research and a highly interesting session on therapeutic area standards, which included a presentation on the development of standards for traditional Chinese medicine (TCM).

 

There were many encouraging moments at CAPI, but one of the greatest highlights, to me, was the number of CDISC Board members that not only attended the bi-annual face-to-face Board of Directors meeting (held in Asia for the first time), but spent the rest of the week thoroughly engaged in the Interchange presentations and associated discussions. Eight CDISC Board members even took time out of their very hectic schedules to participate in a panel discussion and Q&A session for Interchange attendees.

 


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Structured Data Capture Initiative: Adverse Event Reporting

February 11, 2013 at 1:01 PM by cdisc

On 23 January, the U.S. Health and Human Services Office of the National Coordinator held the Standards and Interoperability Framework’s kickoff webinar for their new Structured Data Capture Initiative. This initiative seeks to define “necessary requirements that will enable clinical data captured in an electronic health record during episodes of care to be combined with additional data to supplement other purposes.” One of these purposes is to ensure the reporting of serious adverse events, with the aim of developing an Incident Report for the reporting of such instances.

 

While the HHS ONC has mentioned that it does not want to reinvent the wheel and that the SDC Initiative will collaborate with the international standards development community, of which CDISC is a part, it is important to note the work that CDISC and others have already done in the area of adverse event reporting, and ask the necessary question: is this yet another example of redundancy?

 

In 2008, a pilot project was launched between CDISC, CRIX, Pfizer, Brigham and Women’s Hospital, Partners Healthcare and Harvard Medical School, entitled ASTER, or “ADE (adverse drug events) Spontaneous Triggered Event Reporting.” This project sought to enable automated ADE collection through the EHR using CDISC and IHE’s Retrieve Form for Data Capture. The application that was developed was a novel concept – it directly downloaded data held in the EHR and allowed direct submission to the FDA, all in the correct format for the electronic reporting of individual case safety reports. Follow the Link.


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CDISC and RFD Featured in HHS/ONC Initiative Launch

February 11, 2013 at 10:28 AM by cdisc

On 23 January, the U.S. Department of Health and Human Services Office of the National Coordinator (ONC) of Health IT launched a new initiative: Structured Data Capture (SDC). The specific challenge that the SDC initiative is addressing is that electronic health record (EHR) data has been of limited use for purposes outside of the direct care of a particular patient due to “a lack of uniformity in the terminology and definition of data elements across EHRs.” Thus, the SDC Scope Statement is: “To define the necessary requirements that will drive the identification and harmonization of standards to facilitate the collection of supplemental EHR-derived data.” The initial use cases are electronic case report forms (eCRFs) for research and safety reports. The value of this initiative was cited in the slides and the draft SDC charter:

 

“The identification and harmonization of standards for the structured data capture within EHRs will […] help reduce a) the data collection burden on health care providers by enabling secure, single-point data entry that populates to multiple systems and b) the need to make site-specific modifications to EHR system capabilities in order to enable participation in important reporting and research activities.”


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Meeting of the Institute of Medicine of the National Academy of Sciences

December 10, 2012 at 5:28 PM by cdisc

Large Simple Trials and Knowledge Generation in a Learning Health System

 

“Large Simple Trials (LST) and Knowledge Generation in a Learning Health System” was the topic for a meeting organized by the Institute of Medicine of the National Academy of Sciences. This meeting took place on 27-28 November, and I was invited to give a presentation with the prescribed title: “Getting to Comparable, Computable Data” in a session on infrastructure needs.

 

 

The meeting topic was very specific because there is a perceived need to run more LSTs and the planning committee wanted to explore why there are so few of this type of study actually conducted. Although difficult to find, there were a few examples cited and/or described during the meeting, mostly observational studies conducted by academic universities: Harvard University (VITaminD/OmegA3 – VITAL), Brigham and Women’s Hospital (Post-Myocardial Infarction Free Rx Event and Economic Evaluation (MIFREE), McMaster University (Heart Outcomes Prevention Evaluation -HOPE). There were no regulated research studies recounted.

 


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FDA at the CDISC Interchange – a 10th Anniversary!

November 13, 2012 at 11:08 AM by cdisc

Apparently we were so focused on making this the best Interchange ever that we failed to realize it was our 10th CDISC International Interchange. It dawned on some of us mid-week. The first CDISC Interchange was held in 2003, and Dr. Mark McClellan was the keynote speaker. Dr. McClellan was the FDA Commissioner at the time and, in speaking about the benefits of technology during his keynote, he was quoted as saying: “I think that CDISC will be a big part of moving FDA onto an electronic information architecture where we can realize all of these opportunities. I think this will have a profound and positive impact on our drug review process, allowing us to design trials that can be less expensive and still tell us more about the risks and benefits of a new medical product. And I think that the most significant and perhaps enduring legacy to your efforts could be the very immediate and significant impact it has on improving the lives of patients.”

 

 

Dr. McClellan also spoke of the FDA being a ‘fire hazard’ with so many boxes of paper in storage. The FDA has now moved to their White Oak Campus with far more space and, interestingly, Dr. Janet Woodcock (Director of FDA/CDER) who gave the keynote this year in Baltimore, said that she was told by their document room that they had to ‘stop’….meaning that there is no more room to bring any more paper into the FDA. Speaking specifically about standards, she raised an analogy of the Baltimore fire of 1904, during which the city burned because fire trucks from nearby fire departments did not have hoses that would fit on the Baltimore fire hydrants – there were no fire hose standards!


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Where Should CDISC be Going?

November 13, 2012 at 9:49 PM by cdisc

Session 4 of the CDISC International Interchange conference on 24 October was especially stimulating. It consisted of short, well-delivered and extremely inspiring and promising presentations from various organizations seeking faster and better therapies for patients. A key message: One of the crucial factors to expedite the process of finding new therapies is ensuring the sharing of accurate data through standards.

 

 

Everyone is going to be a patient, and we all happen to know someone with a brain disorder, Dr. Magali Haas of One Mind Research opened her presentation. Dr. Haas spoke of the ‘moon shot’ initiative of President John F Kennedy to put a man on the moon; it is based upon this successful challenge that Patrick Kennedy has now launched the One Mind initiative to cure brain disorders in this century. Dr. Magali stated, “We will not accomplish this without common standards for data. We need to integrate solutions and new practices to improve the quality of lives. CDISC is one of the key organizations that will ensure the development of common data elements for traumatic brain injuries.”

 

 

Dr. Charles Hugh-Jones of sanofi, DataShare and the CEO Roundtable on Cancer apprised the audience on the ongoing project of implementing data sharing among biopharmaceutical companies within the environment of Oncology.


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FDA Public Meeting on Transport Standards – 5 November 2012

November 9, 2012 at 7:19 PM by cdisc

FDA Public Meeting on Transport Standards – 5 November 2012 On 5 November, the Food and Drug Administration (FDA) announced a meeting entitled “Regulatory New Drug Review: Solutions for Study Data Exchange Standards” with the purpose of soliciting input from industry, technology vendors, and other members of the public regarding the advantages and disadvantages of current and emerging open, consensus-based standards for the exchange of regulated study data. The meeting was held at the FDA’s White Oak Campus in a large room with ~ 15 round tables, each seating 5-8 individuals (i.e. about 100 attendees). There were at least a dozen FDA representatives present, 5 with speaker/facilitator/presenter roles. This is simply a brief summary with the key points that came across to me, with a goal of reporting this objectively.

 

 

Mary Ann Slack (FDA, CDER OPI) opened the meeting reiterating the purpose to get industry input, objectively without debates. She said that they really wanted to have a discussion and that they will provide an e-mail address for thoughts that folks would like to send, even after the event. She cited some scenarios that will be placed on the FDA website to convey the ‘pressing challenges’ that FDA has with respect to receiving and reviewing data. Ms. Slack highlighted a few of the comments that were received in writing, including the need for high quality standards across the spectrum of research, recommendations including an end of Phase II data standards meeting for those developing new treatments and the need for more consistency---governance is key, she said.


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CDISC International Interchange 2012 - Train the Trainer Session

October 29, 2012 at 9:51 AM by cdisc

CDISC International Interchange 2012 initiated with one of the most interesting educational sessions that I have ever attended in a very long while, Train the Trainer session! The session took place on Sunday, 21 October 2012 at the Renaissance Harborplace Hotel in Baltimore, MD. This course was developed specifically for CDISC authorized instructors so that CDISC training can be delivered in the best possible way to our members and stakeholders.

 

 

 

 

The session was tailored to train instructors and presenters on global teaching and presentation skills that would motivate and stimulate the profound attention of the attendees in the material delivered. The session started at 9:00 AM and was supposed to end at 5:00 PM, but it did not end until 5:45 PM where active participation and excitement of discovery kept the attendees interested until the last minute. Attendees, who are also CDISC instructors were urged to participate continuously, analyze and discover new ideas and training methods throughout the day. Creative and positive input led to self-discovery of new teaching techniques, this atmosphere of active and analytical participation helped the attendees discover a new variety of interesting and exciting teaching methods even before they received instructions and notes from the instructor.


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Update: Final Rejection of DataSci Patent Application

August 21, 2012 at 6:09 PM by cdisc

CDISC would like to thank all those who followed the metadata patent issue. Late last week the US Patent Office officially issued a “Final Rejection” notice to the patent applicant. According to the US Patent Office: “A final Office action," in this case a final rejection, “issues when the applicant's response to the prior Office action fails to address or overcome all issues. An applicant’s only response to a final Office action is either compliance with the requirements or appeal to the Trademark Trial and Appeal Board.”

 

Please note that the applicant has a 3 month window in which to reply to this “final action” so we will continue to follow any further progress. We have consulted the formerly mentioned IP attorney about this issue and have been cautioned that patents can be saved from "final" rejections through amending the claims, filing a continuation, etc. We are hopeful, however, that based on the description above of what is meant by a “final rejection” that this application will not have a chance to move forward. We will report back on any further developments. Thanks again for your support on this issue.


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Support CDISC at Upcoming FDA Meeting Solutions for Study Exchange Standards

August 21, 2012 at 6:20 PM by cdisc

The FDA recently published their announcement of a public meeting to discuss Solutions for Study Exchange Standards. The notice includes directions for how to register to attend the meeting (the email address, however is incorrect. Please refer to correct address at the end of this entry), and also a list of questions related to the use of standards, including asking for input on comparing HL7 transport standards to CDISC ODM.

 

 

This may be our best opportunity to convince FDA that an XML transport standard based on ODM for CDISC SDTM, SEND and ADaM content would be a better solution for submitting data than use of HL7 healthcare standards. We believe this forum will highlight the advantages of using the CDISC Operational Data Model (ODM), which is the basis for define.xml and a current component of the FDA study data standards. ODM has been successfully adopted by many researchers in both industry and academia, as well as technology vendors for transferring clinical data, metadata and terminologies with audit trail in a fully compliant manner.


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Join the Challenge, and Gain the First Mover Advantage!

August 7, 2012 at 7:24 PM by cdisc

Winner gets the CDISC Innovation Award with Recognition from HHS-ONC, DIA, FDA and CDISC!

 

 

At this year’s DIA meeting in Philadelphia on 26 June, CDISC, HHS/ONC and FDA issued a ‘challenge’ to use EHRs for regulated research. Specifically, research study sponsors were challenged to use at least two different electronic health record systems at different sites to conduct a multi-site, multi-visit, standards-based regulated research study. The panelists at DIA spoke on the feasibility of this challenge, based upon technology and data standards and processes that have been developed over the past decade. In addition, a case study was presented during this session about a research study being conducted currently at Florida Hospital using the Cerner EHR system. Despite the potential and demonstrated benefits of this approach, the clinical research industry has not yet embraced these new methods and standards to conduct research studies.

 

This challenge will provide FDA, HHS/ONC and CDISC a means to assess the remaining barriers as well as the opportunities to streamline regulated research and increase its capacity throughout the US and the world as EHR adoption is being encouraged and increasing rapidly. Wayne Kubick, Chief Technology Officer (CDISC), spoke first at the DIA session: “CDISC has been doing demonstrations of its Healthcare Link methodology for years now, at HIMSS and at DIA. By adopting the CDISC-IHE profiles used in the CDISC Healthcare Link solution, EHRs can readily implement the standards and profiles to enable the collection of a high quality research dataset that is needed for any regulated research study.”

 


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New Chair for CDISC Coordinating Committees in China

August 6, 2012 at 1:09 PM by cdisc

The CDISC China Coordinating Committee (C3C) was initiated in 2008 when Sandy Lei of J&J came to China and initiated a CDISC group. President, Rebecca Kush, also visited that year and a half-day workshop was held with Lei and Kush as speakers. The first Chair, Simon Wang of Parexel, was elected and a Charter was written. The C3C has since sponsored two Interchanges at Fudan University and more recently initiated a great group that has been validating translations (provided by Absolute Systems Clinical Data Co., Ltd.) and performing translations of the CDISC standards into Chinese. This group is known as CSTAR (CDISC Standards Translation and Review).

 


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Regulatory Science in Japan

August 6, 2012 at 8:20 AM by cdisc

“Japan’s Strategy in the Era of Global Development” was the title of the presentation given at the CDISC Japan Interchange on Thursday, 12 July by Tatsuya Kondo, M.D., Ph.D., Chief Executive, Pharmaceuticals and Medical Devices Agency (PMDA). This leader of Japan’s Regulatory organization provided a very informative keynote presentation expressing appreciation of the value of standards. Many thanks to Dr. Fukushima, head of the Translational Research Informatics Institute (TRI) in Japan, for extending the invitation. After his presentation, Dr. Kondo and two of his staff met with leaders from CDISC Global Operations, TRI, CDISC Board (Dr. Lastic) and the CDISC Japan Coordinating Committee.

 

Dr. Kondo stated that “the purpose of Pharmaceutical Affairs is to improve the public health through regulations to secure quality, efficacy and safety of pharmaceuticals and medical devices and take necessary measures to promote R&D, where the reliability must be verified”. There are three primary roles for PMDA in their quest to improve the public health and safety of Japan: 1) to reviewing applications for marketing approval of pharmaceuticals and medical devices; 2) to conduct safety measures, and 3) to provide relief to people who have suffered from adverse drug reactions or infectious diseases.

 


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CDISC Workshops in China in July – Thanks to IBM and AmCham

August 5, 2012 at 8:50 PM by cdisc

In January 2012, CDISC was contacted by Nanping (Lisa) Li, Healthcare Strategy & Business Development Executive, IBM, who informed us that CDISC would be an important focus for IT standards in China, in particular, with respect to a new program that has been launched between China and the US through AmCham. Ms. Li sits on the Steering Committee of the Healthcare Cooperation Program (HCP).

 

 

 

According to a Press Release from 26 June: “AmCham China's Healthcare Cooperation Program (HCP) today signed a memorandum of understanding (MOU) with the Health Human Resources Development Center of the Chinese Ministry of Health, opening a path to increased cooperation. The MOU will help foster multi-level exchange between China and the US in the healthcare sector and provide a platform for high-level US-China dialogue on healthcare reform, medical personnel training and technology exchange.” See this link for the full press release.

 

According to Jun Zhou, Executive Director, AmCham is working to make it easier for companies to do business in China; his key project is the Healthcare Cooperation Program. The two workshops that AmCham and IBM planned, with CDISC as a core theme, took place in Beijing on 16 July and Guangzhou on 19 July. AmCham and IBM sponsored the workshops, along with support from CDISC, especially Sheila Leaman, CDISC Manager of Global Relations.

 

 


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CDISC Intellectual Property

July 27, 2012 at 5:01 PM by cdisc

CDISC retains IP ownership of all of its standards to ensure that CDISC Standards remain open and free, Even when the standards are translated into other languages, the IP belongs to CDISC.

 

 

CDISC standards are created through a consensus-based process that includes many different people who contribute their time and expertise. Thus, the value should serve everyone and the IP be protected. Some standards in other industries were developed in a manner that included proprietary portions such that users were charged royalties. The desire to prevent royalty charges or ownership by any one organization or individual formed the basis for the CDISC IP Policy that is now posted on our website.


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CDISC 2012 Japan Interchange, Tokyo, Japan

July 23, 2012 at 10:27 AM by cdisc

This year marks the 10th anniversary of the Japan CDISC Coordinating Committee (J3C), and in celebration of this milestone, CDISC honored their long-standing support at the 2012 Japan Interchange in Tokyo.

 

Questions and comments are welcome here!


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Metadata Patent - Invitation to the Entire Health Care Community To Participate

July 23, 2012 at 1:31 PM by cdisc

Last week CDISC sent a letter to many of our members alerting them to a potentially damaging and costly patent application which is currently under review by the United States Patent Office. The text of the letter is below and was prompted in part by a thread on Linkedin which can be found here.

 

The jist of the patent is this: a company, DataSci, filed a patent application in 2009 that effectively patents the use of metadata in clinical research. If this patent is granted there is a real possibility that a fee will be due to the patent holder for any use of metadata over the internet for every study done by any BioPharmaceutical company, academic research institution, government agency – basically ANY clinical research. See the original email below for more details and links that provide additional information.

 

Almost immediately after the email went out CDISC was contacted by Pharmaceutical, Biotech, Government, CRO and Technology company representatives company representatives asking how they could help prevent this patent from being approved. Most have forwarded the original email to their legal counsel and are looking into the process to protest this patent. Several of the large Pharma companies are also discussing how to combine efforts to fight this patent application.

 

CDISC appreciates all this effort and the support shown by our members. We will periodically update this blog with the status of these efforts.

 

Original email follows:


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Notes from the Korean Workshop and Symposium

July 17, 2012 at 5:33 PM by cdisc

Seoul University

9-10 July 2012

Seoul, South Korea

 

Greetings from Seoul! Members of our CDISC team have a busy month ahead, with CDISC workshops and an interchange scattered around the Asian continent. We have begun our journey with a trip to Seoul, South Korea, where Dr. Rebecca Kush, CDISC President and CEO, Wayne Kubick, CDISC Chief Technical Officer, Dr. Pierre-Yves Lastic, CDISC E3C Past-Chair and Chair-elect of the CDISC Board of Directors, and Dr. Kiyoteru Takenouchi, CDISC J3C Past-Chair and Board Member, have all given presentations to the K3C and interested parties from the Korean Society of Clinical Development at the CDISC Korea Workshop/Symposium about the importance of using CDISC standards for clinical research. A general overview of the standards and activities was given on the first day, and in-depth training over the standards and how the work together end-to-end was offered the second day.

 

Questions and comments are welcome here!


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DIA 2012 – eSubmissions Session, 25 June 2012

July 9, 2012 at 4:42 PM by cdisc

For those of you who were unable to attend the DIA 2012 Annual Meeting in Philadelphia at the end of June (or those of you who may have missed this session), there was an excellent set of presentations from FDA representatives. Here is my summary; I would welcome additions and/or comments.

 

The session was chaired by Dr. Chuck Cooper. Mary Ann Slack spoke first on the topic of CDER Data Standards. She opened: “We cannot improve efficiency or innovate without standards.” CDER is working, with other FDA centers, on end-to-end standards to support a standards-based review environment. They have posted a list of therapeutic area standards that they would like to have developed, to add to the existing standards (which pertain to all research studies); they have also created a ‘notional timeline’ for these. However, she stated clearly that FDA should not drive the standards development; CDISC and the Critical Path Institute, with patient advocacy groups, are working on these, with nine of the therapeutic area standards already in progress. “CDISC, C-Path and FDA collaborate constantly.” (See the CDISC-C-Path Press Release from 23 June 2012 about CFAST).

 

Questions and comments are welcome here!  


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Where is caBIG Going?

July 9, 2012 at 10:56 PM by cdisc

As many of you know, changes have been taking place with the Cancer Biomedical Informatics Grid (caBIG) initiative, a large program of the U.S. National Cancer Institute (NCI). I am writing this blog with assurance that the terminology that has been supported for CDISC (and FDA) through the NCI’s Enterprise Vocabulary Services (EVS) is ‘alive and well’ and freely available, as usual. I also want to make an effort to clarify the history and describe what is transpiring with respect to caBIG as I write.

 

In March 2011, a report by the NCI’s Board of Scientific Advisors, entitled ‘Assessment of the Impact of the NCI CaBIG’, was released. Based upon these findings and recommendations, an Oversight Sub-Committee was formed to further review the caBIG projects and make additional recommendations (Members of this Sub-committee are listed at the end of this blog). Dr. Harold Varmus, the head of NCI, spoke to the Oversight Sub-committee at its initial meeting in June of 2011. His hope is that this Sub-committee serves as a model for program reviews and external advisory groups. Participants in the development of the BSA report (Drs. Stein and Califano) presented their findings to the Sub-committee after which John Czaikoski presented a response from the NCI, including actions they had taken to streamline management and to scale back certain activities that had been identified as having a less than favorable return with respect to NCI resources spent.

 

Questions and comments are welcome here!  


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The “Learning Health System” (LHS)

June 11, 2012 at 7:26 PM by cdisc

The Learning Health System Summit took place on 17-18 May at the National Press Club in Washington, DC. It was the culmination of intense planning that occurred via phone several times monthly from the time of the CDISC Interchange in October 2011 (and even before, but that is when CDISC learned about this initiative). Dr. Charles Friedman gave a keynote address on his vision of the Learning Health System (LHS) at the CDISC International Interchange in Baltimore in October 2011 and spoke afterwards with then Board Chair, Dr. Frank Rockhold and myself about his plans to take this concept forward. [He had recently left his position as chief scientist in the Office of the National Coordinator to assume a position at the University of Michigan.] Chuck has published about the LHS in Science Translational Medicine (10 November 2010); directly aligned with the CDISC Vision, the LHS focuses on the fact that research data comes from healthcare and, in turn, should inform clinical care decisions. This cycle is said to take 17 years currently (for research results to end up in clinical decision support). As Chuck would say, we would like to see this go to 17 months, weeks or minutes!

 

The opportunity that took place last month was afforded by Mr. Joe Kanter of the Kanter Family Foundation and Kanter Health. He funded the LHS Summit; the Summit Planning Committee (including Frank Rockhold and myself) and was led by Dr. Friedman, assisted by Josh Rubin (Executive Director of Kanter Family Foundation) and students from the University of Michigan.


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"Pushing the Envelope"

June 11, 2012 at 7:33 PM by cdisc

In early May, Bron Kisler (CDISC VP, Strategic Initiatives) and I spent 5 days (Saturday through Wednesday) at JIC and ISO meetings in Vancouver, Canada---okay, there are far worse places to spend a weekend working, and the food there was wonderful, especially since the locals were talking us to their favorite places. Most importantly, there were important goals to accomplish for CDISC: 1) to enhance the governance of the JIC and 2) to get BRIDG through the entire process to become an ISO/CEN standard. I will provide a bit more detail on each of these, but suffice it to say that it was a productive week and we are indebted to many wonderful CDISC friends from around the globe.

 

The Joint Initiative Council (JIC) began as a group of 3 SDOs, i.e. Standards Developing Organizations, namely ISO, CEN and HL7. They added CDISC (after a 6 month probation period) when we proved to be 'good citizens' working with the other three, particularly in areas that relate to clinical research. Two more SDOs were then included-GS 1 and IHTSDO. After leadership from HL7 and CEN, CDISC was asked to Chair the JIC, and Bron has filled this role for over a year now.


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2012 Europe Interchange — EHRs

May 17, 2012 at 4:33 PM by cdisc

David Moner, Clinical Trials Powered by Electronic Health Records

 

David Moner of Universitat Politecnica de Valencia was first to present during the Electronic Health Record (EHR) session on the second day of the European Interchange. Mr. Moner began his presentation by summarizing the current status of EHR use in the healthcare industry; he detailed that, while a great deal of effort and investment has been put toward the adoption of EHR systems, and although this has benefitted healthcare delivery, so far it has not been as clearly beneficial for clinical research. Specifically, the concept of EHR data reuse remains an unresolved issue.  Read More.

 

Kiyoteru Takenouchi, Japanese Sentinel and MIHARI Project

 

Kiyoteru Takenouchi of CMIC was next introduced, and began his discussion by describing how the EHR is currently in use in Japan. At this time, 90% of large hospitals in Japan have Computerized Physician’s Order Entry (CPOE). The PMDA’s (Japan’s FDA) MIHARI Project focuses on having four working groups for each information source: 1) reimbursement claims and Diagnosis Procedure Combination (DPC)/Diagnosis Related Group (DRG), 2) hospital information system, 3) spontaneous adverse events reported to PMDA, and 4) post market surveillance collected by pharmaceutical companies. Data is changed to a standard format when it is sent to storage, which allows reuse for many purposes, such as referrals to other clinics and hospitals.  Read More.

 

 

Pierre-Yves Lastic, Report from the EHR4CR Project

 

Pierre-Yves Lastic of Sanofi Aventis followed Mr. Takenouchi, and presented on the Innovative Medicine Initiative’s (IMI) EHR4CR Project, a four-year project (2011-14) with a budget of over 16M euros with the objective of promoting the wide-scale reuse of EHR data to accelerate regulated clinical trials across Europe (although now that the FDA is a part of the advisory committee this is anticipated to expand). The project works with 10 pharmaceutical companies, 22 public partners from academia, hospitals and SMEs (including CDISC), and five subcontractors. To date, this project is one of the largest public-private partnerships working on reuse of EHR data for clinical research. Reuse of EHR data offers opportunities to advance medical research, improve healthcare and enhance patient safety. 


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The CDASH E2B (Serious Adverse Events) Project

May 16, 2012 at 12:17 PM by cdisc

Presented by Sonia Araujo, Medidata Solutions and Gary Walker, Quintiles


“The idea of the CDASH E2B project initiated ten years ago, but just until 2010 it started taking effect” said Barry Burnstead, a member of the CDISC European Coordinating Committee (E3C) and chair of the CDASH session at the CDISC European Interchange in Stockholm.

 

Sonia Araujo of Medidata was the first presenter on the CDASH-E2B session

 

Sonia Araujo declared that the purpose of the project is to identify and describe the International Conference on Harmonization (ICH) E2B fields that are collected at investigational sites for serious adverse event reporting. Hence, a CDASH-E2B team was formed by CDISC and led by Rhonda Facile.

 

Members of the CDASH E2B group represent a good cross section from the healthcare industry coming from both Europe and U.S.A. The E2B group consists of representatives of biopharmaceutical companies along with software vendors, CRO representatives, sponsor companies as well as independent organizations such as the U.S. Office for Policy.


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CDISC Interchange Europe 2012 - “Standards Accepted for Progress; CDISC the Reliable Partner"

May 8, 2012 at 1:15 PM by cdisc

The Value of Standards, Collaboration and Communication were the focus at the opening of the CDISC European Interchange in Stockholm. Paula Brown Stafford, Chair, CDISC Board of Directors, opened the Interchange by stating the CDISC mission and vision “To Inform Patient Care & Safety Through Higher Quality Medical Research”. She invited all attendees to participate in this vision by acting as advocates for standards within their organizations. She stated that standards ensure high quality medical data and help us achieve medical breakthroughs faster. She also provided the audience with a summary of the CDISC Board of Directors meeting, which took place on 16-17 April in Stockholm. (See blog by Dr. Kush.)

 

Dr. Rebecca Kush, President and CEO of CDISC, thanked the E3C, the E3C Program Committee, CDISC team members and everyone who contributes in any way to CDISC progress. Volunteers are the ‘heart and soul’ of CDISC. In particular, she thanked Joerg Dillert, who chaired the EU Interchange Program Committee this year and came up with the theme (which is the title of this blog).

 

 

 

 


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2012 Europe Interchange - BRIDG

May 8, 2012 at 1:24 PM by cdisc

After two days of training on SDTM, ODM, PRM and ADaM, the official kick off of the Interchange began on Wednesday, 18 April 2012. The program on Wednesday featured two opening plenary sessions followed by two parallel track sessions, the first of which focused on BRIDG and CDASH. I personally sat in on the BRIDG session, and had the opportunity to listen to presentations given by Sue Dubman of Genzyme, Isabelle Zegher of Perceptive Informatics, and Joerg Dillert of Oracle.

 

Sue Dubman, BRIDGing to Improve Connection with Patients and Providers: A Case Study Ms. Dubman, who is also a director on the CDISC Board, discussed the benefits of adopting BRIDG, incorporating the example of Genzyme’s RegistryNXT! Program, a web-based disease registry platform that consolidated existing Genzyme Lysosomal Storage Disorders (LSD) registries and other rare disease registries, with BRIDG as its underlying information model.

 


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2012 Europe Interchange - ODM/XML Session

May 8, 2012 at 1:31 PM by cdisc

I had the opportunity to listen for the first three presentations of Session 5 at the 2012 Europe Interchange in Stockholm. Dr. Philippe Verplancke of X-Clinical (and also a CDISC ODM Instructor) chaired this Session, which centered around ODM and XML.

 

Jozef Aerts, Multipurpose Usage of the New “Study Design Model in XML” (SDM-XML) Jozef Aerts of University of Applied Sciences FH Joanneum, Vienna, Austria presented on the multipurpose usage of the new Study Design Model in XML (SDM-XML)

 


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“Ask the Expert” Session at the CDISC European Interchange – April 2012

May 8, 2012 at 1:44 PM by cdisc

“Ask the Expert” session of the CDISC European Interchange 2012 was quite remarkable. Stimulating questions related to the CDISC achievements and other issues grabbed the attention of the audience. In fact, this was arguably the best session of 2012 CDISC Interchange since the two excellent Plenary Sessions had not allowed time for Q&A, while this session gave the audience plenty of opportunity to ask many of these Plenary speakers about issues they really wanted to understand.

 

The panel was formed of international experts in the healthcare/research industry: Charles Cooper of FDA, Bernard De Bono of the European Bioinformatics Institute, Bron Kisler and Wayne Kubick of CDISC and Pierre-Yves Lastic of Sanofi and the E3C answered inquiries from the attendees.

 

 

1. Does the FDA expect the community to use the latest SDTM Implementation Guide and how is this going to be approached?

 


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ACRO’s Pleas at FDA Public Hearing on Modernization

May 8, 2012 at 1:51 PM by cdisc

Still resonating for me are quotes from ACRO Executive Director, Dr. Doug Peddicord, at a recent FDA public hearing entitled "Modernizing the Regulation of Clinical Trials and Approaches to Good Clinical Practice." On behalf of the Association of Clinical Research Organizations (ACRO), Dr. Peddicord proposed a Chief Innovation Officer for FDA, among other recommendations.

 

Cited below is a segment from the ACRO press release on this topic:

 

Peddicord expressed concern about the slow progress that has been made since the release of the FDA's "Critical Path" whitepaper in 2004. He noted that while some FDA-supported efforts, such as the C-Path Institute and the Clinical Data Interchange Standards Consortium (CDISC) have had success developing tools to advance drug development, other efforts have fallen short. Notably, Peddicord singled-out the Clinical Trials Transformation Initiative (CTTI).

 

"While CTTI is well-intentioned, it has not taken on projects that have the potential to be 'transformative,’" said Peddicord. "Every effort at innovation that the FDA supports, directly or through the funding of public-private collaborations, should be measured against three objectives: does it make the drug development process faster, cheaper or more productive."

 


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The Development and Status of SEND - Lessons Learned during the FDA-SEND Phase 2 Pilot

May 8, 2012 at 3:01 PM by cdisc

Novo Nordisk Presentation during the CDISC Interchange Europe 2012


Gitte Frausing of Novo Nordisk presented on her CDISC SEND experience during the CDISC European Interchange in Stockholm on 18-19 April. The focus of her presentation was on lessons learned from the FDA-SEND Phase 2 Pilot, in which Novo Nordisk participated. The value of a close collaboration among the SEND team, the CDISC Terminology team and the FDA was readily apparent from this presentation.

 

Gitte described how different terms with varied definitions may cause inconsistencies and inaccurate results within the non-clinical analysis. She illustrated her point of view with some examples of inconsistencies within the area of microscopic findings: one of the findings showed a liver having a 3 millimeter pale area with surrounding hemorrhage, which is actually considered two findings in SEND and should not be included in the same record. Gitte also mentioned that having no place to incorporate certain data in the SEND domains caused loss of information due to the lack of standardization in the data capture phase. This was one of the ‘lessons learned’ that the FDA agency has found during their analysis of the submitted data.

 

Another example Ms. Frausing provided was that FDA asked Novo Nordisk to test the terminology for the severity variable in SEND standard; the outcome was to ensure the validity of the terminology already created by the SEND terminology team.

 


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FDA Presentation at the CDISC European Interchange

May 8, 2012 at 3:55 PM by cdisc

FDA Presentation at the CDISC European Interchange We were very fortunate to have Dr. Chuck Cooper, FDA/CDER, join us at the CDISC European Interchange last month! (Mary Ann Slack, also of FDA, had also planned to present in this session; however, she was unable to travel to Stockholm at the last minute. Dr. Cooper combined her slides with his and spoke for both of them.) As the E3C Chair, Pierre-Yves Lastic, commented…the attendees were very pleased to have an FDA representative there ‘in flesh and blood’ to talk with them and answer their questions.

 

Dr. Cooper’s slides will be made available to the Interchange attendees, but here are a few highlights/quotes for those who were unable to attend:

 

The electronic format and standards are critical for FDA.

 

“We cannot improve efficiency or innovate without standards."

 

We want to improve regulatory decision-making through better access to structured scientific data.

 

Non-standard electronic data limits quality and efficiency during the review process.

 

PDUFA V is coming; PDUFA IV ends in late September 2012. The FDA is building a clinical trial repository (CTR), formerly called Janus, which is BRIDG-informed and is receiving input from the division data standards heads and clinical and statistical reviewers. They are using an OpenCDISC enterprise tool and will eventually share their validation checks.

 

The vision at FDA is a ‘standards-based end-to-end fully electronic review environment’.

 

 

By Dr. Rebecca Kush

CDISC, President and CEO


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Greetings from the CDISC European Interchange in Stockholm

April 16, 2012 at 6:13 PM by cdisc

 

 

Greetings from the CDISC 2012 European Interchange in Stockholm, Sweden! Our team has been hard at work to ensure that this year’s European Interchange is our most successful yet, and we are off to a great start! On-site preparations for the Interchange began on Friday, and after preliminary meetings and a tremendous amount of unpacking and arranging, the CDISC registration booth was open for those attending CDISC Education courses to check in this morning.

 

 


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CDISC Keynote in Japan National Program Life Science Innovation

March 26, 2012 at 8:58 PM by cdisc

The Growing Role of Academia in Japan - March 2012 Organized by Translational Research Informatics Center (TRI)

 

On behalf of Dr. Fukushima, the director of the Translational Research Informatics Center (TRI), Kobe, Japan, Dr. Rebecca Kush was invited to be a keynote speaker at the final session of a meeting that took place on 2-3 March 2012 in Tokyo; the theme was Life Science Innovation: The Growing Role of Academia in Japan. This final session was entitled “Coordination, Support and Training Program for Translational Research” and was slated as “one of the most important national projects of the Japanese Ministry of Education, Culture, Sports, Science and Technology (MEXT)”.

 

TRI and MEXT developed this program over the course of 5 years to increase the application of basic research to patient care, so called Translational Research, through promoting organizations, within universities to become centers of translational research. Moreover, as a part of the program, TRI has also been working on projects in relation to CDISC standards and has translated CDISC standards into Japanese.

 


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CDISC in Japan

January 26, 2012 at 12:25 AM by cdisc

November 2011, Rebecca D. Kush, PhD, President and CEO, CDISC

 

Japan has a long established reputation for quality, based upon processes that build quality in from the beginning. The value of CDISC increases dramatically as it is implemented upstream in the medical research process---in developing case report forms or protocols. I was honored and pleased to have been invited to speak at the 3rd Global Quality Assurance Conference held in November 2011 in Kyoto (which was even more remarkable than usual, during the peak of the fall color changes). Yoshio Tsukada of GSK and the leader of the Japan CDISC Coordinating Committee (J3C) organized a pre-conference workshop entitled “CDISC Makes You Happy”. The crowd numbered ~ 250 in the splendid Kyoto Conference Center (see photos); they gathered to hear the 6 speakers of this session on Sunday afternoon, 13 November.

 

 

 

 

The main messages I took home from this session are shared here with you:

 

Mr. Yoshio Tsukada, as the Chair, introduced the session and speakers. He presented CDISC as one of the significant key players for efficiency for ALL stakeholders. There is a need for a simple flow in clinical research, from collection through reporting, which CDISC facilitates.

 


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CDISC Activities in Japan – November 2011, R. D. Kush

January 26, 2012 at 1:04 AM by cdisc

At 23:00 Japan time on Thursday, 10 November, after traveling for ~ 22 hours (starting from JFK in New York City) I arrived at the Seahawk Hilton in Fukuoka, Kyushu. I made an effort to get some sleep that night since my presentation was scheduled for 17:00 on Friday, 11 November at Kyushu University. It was an interesting feeling to return to Kyushu ~ 25 years after I had given a presentation there on an entirely different subject when I was living and working in Tokyo…before CDISC was even a dream. This area has experienced significant growth, yet it is still beautiful with its seaside location and nearby mountains and pine trees. The next morning I realized I was right on the water, at the tip of Japan and only about an hour from Korea by boat.

 

Dr. Ken Toyoda had been inviting me to speak in Kyushu for several years now, so the Kyoto QA Conference (see previous blog) offered an opportunity to do so on the prior Friday. Approximately 40 doctors, dentists and researchers, most in white coats, were in attendance for the presentation on CDISC. Dr. Toyoda leads the ISO TC215 group in Japan and I know him from ISO meetings; he also launched a Clinical Research support organization/CRO and works with the Center for Clinical and Translational Research at Kyushu University. He and Junji Kishimoto, who created an English business card especially for my visit, provided translations and comments at various points throughout the lecture. I could not resist but begin my presentation with a slide showing only 11-11-11. That was the current date and the only day of this year when metadata was not essential to interpret the date!

 


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Computational Science Symposium, Silver Spring, MD

January 22, 2012 at 12:29 PM by cdisc

March 19-20, 2012

 

I like to compare improving efficiency in clinical trials to eating an elephant; where do you start? With an industry that spans hundreds of companies, thousands of people all over the world, and a process that must be rigorously controlled, at some point you need to make a decision to start somewhere and build from there. This is the thought behind the FDA/PhUSE Annual Computational Science Symposium (CSS). FDA and PhUSE have worked together to define the first pieces of the elephant by defining six working groups. The topics of these working groups include: data validation, reducing risk with site selection, integrating data, converting data (CDISC SDTM), implementation of CDISC models, developing standard analyses, and non-clinical data standards implementation (CDISC SEND). Over time these working groups will evolve and the topics and issues of greatest interest will rise to the top. http://www.phuse.eu/Working-Groups.aspx

 

But let’s not get ahead of ourselves; these core topics are already challenging by themselves. How are we, as an industry, going to make significant advancements on this idea? Powerpoint, while good at presenting an idea, is not ideal for collaboration. The model of presenting and listening needs to evolve; we need to sit down, roll up our sleeves, dive into the details and begin putting a plan in place on how to move forward. It is understood that solutions are not going to be miraculously discovered in a two-day meeting. Working groups initialized at the CSS 2012 will continue throughout the year documenting progress on the PhUSE Wiki. CSS 2013 will start with a presentation of the work that had been completed and a kick off of next year’s goals.

 

 


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EHR Roundtable Meeting

January 9, 2012 at 8:55 AM by cdisc

Philadelphia, Pennsylvania

29 November 2011

 

 

At the end of November, I had the opportunity to sit in on an Electronic Health Record (EHR) Roundtable discussion, which was organized by Tufts Center for Drug Development, CDISC and HL7 and took place at the GlaxoSmithKline complex in central Philadelphia, PA. There were exciting updates about the status of EHRs globally, with primary topics of discussion revolving around the expansion of EHR usage to assist in promoting safety and to enable research.

 

EHRs are gradually being adopted worldwide. Already, nations like Singapore have adopted nationwide EHR systems. One of the greatest hurdles to the adoption of EHRs for research has been regulatory ‘approval.’ Acceptance by regulatory entities of EHRs is critical for expanded adoption, but at the present moment there continue to be concerns voiced and misperceptions communicated, which encourages the continued practice of inefficient re-entry of data from paper.


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Collaboration in Medical Research & Healthcare Industries Supports Faster & Safer Drug Development

December 16, 2011 at 5:00 PM by cdisc

Last year Critical Path Institute (C-Path) and Clinical Data Interchange Standards Consortium (CDISC) launched a landmark joint project to develop a successful Alzheimer’s Disease (AD) data standard and research database. Data from eleven AD clinical trials from seven of C-Path’s Coalition Against Major Diseases (CAMD) member organizations (who are also CDISC members), was converted into the CDISC SDTM standard. During the process, new formats were added to SDTM to create a resulting new therapeutic area specific standards package, the CDISC AD standard. The data were then ready to be aggregated, and the result was a database incorporating detailed data from over 4,100 individuals afflicted with AD, a groundbreaking achievement that will assist researchers in developing safer and more effective treatments for those suffering with AD.

 

The collaboration between CDISC, C-Path, government agencies, academia, patient groups and the AD clinical community in developing the CDISC AD standard is a valuable model of how a successful consortium can support faster and safer drug development. In much the same way that CDISC has collaborated with C-Path to develop Alzheimer’s data standards, CDISC and the Innovative Medicines Initiative (IMI) have recently signed a Memorandum of Understanding (MOU), agreeing to collaborate for the shared purpose of accelerating the development of new therapies for patients worldwide.

 

IMI, the largest public-private partnership in Europe, supports further innovation in healthcare through the formulation of partnerships between industrial and academic experts to aid in the creation of a more cooperative environment for R&D, encouraging the development of safer and more effective drugs for patients. IMI seeks to address certain inadequacies in R&D causing delay in the drug development pipeline through four research priorities: 1) predicting safety, 2) predicting efficacy, 3) knowledge management and 4) education and training. With knowledge management in particular, IMI seeks to more effectively utilize data to determine safety and success.

 


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Oncology Colloquia at the CDISC International Interchange 2011 in Baltimore, MD

December 15, 2011 at 3:28 PM by cdisc

 

The Oncology Colloquia was one of six Colloquia sessions held during the CDISC International Interchange 2011 on 6 therapeutic areas: Oncology, Virology, Pain, Diabetes, TB and Imaging.  Bron Kisler, VP of Strategic Alliances at CDISC, initiated the session introducing himself, Bron’s background with CDISC is on Terminology.  He was one of the first people with CDISC to work on Therapeutic projects beginning with the TB and Acute Coronary Syndrome projects back in 2006.  “We have seen growing interest in disease specific standards from the CDISC community and FDA as well as communities new to CDISC including NIH institutes, foundations and professional societies”, Bron mentioned.  He also stated that one of the nice things about Oncology is that we don’t have to start from scratch due to the great work already done across the National Cancer Institute (NCI) community.  During the meeting, Dianne Reeves from NCI provided an in-depth orientation of this work, which was followed by a working session.

 

The attendees, who were also active CDISC team members, represented a good cross-section of organizations: Astrazeneca, Celgene Corporation, Critical Path Institute , eClinical Solutions, Eli Lilly, FDA, GlaxoSmithKline, Genentech, NCI, Otsuka Pharmaceutical and Pharmastat.  CDISC and C-Path are partnering on numerous disease projects with 9 therapeutic areas in the works and at various stages of development.  CDISC is so pleased to be partnering with the C-Path team out of Tucson, AZ on this new work as they bring incredible value including their project management expertise.  It was also exciting to hear that FDA was very pleased with the growing CDISC C-Path relationship.


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Partnering for Cures: A FasterCures Meeting

December 6, 2011 at 2:06 PM by cdisc

Grand Hyatt Hotel, New York City

7-8 November 2011

 

A fascinating panel at Partnering for Cures in New York City was that of the ending plenary session, where leaders from academia, non-profit and for-profit companies, and government came together to discuss best practices in successful collaborations. Those on the panel were:

 

  • Gordon R. Bernard, M.D., Professor of Medicine, Associate Vice Chancellor for Research, and Senior Associate Dean for Clinical Science, Vanderbilt University
  • Kathy Giusti, MBA, Founder and Chief Executive Officer, Multiple Myeloma Research Foundation
  • Brian Harvey, M.D., Ph.D., Vice President, U.S. Regulatory Policy, Sanofi
  • Thomas R. Insel, M.D., Director, National Institute of Mental Health (NIMH), National Institutes of Health
  • Jeffrey M. Trent, Ph.D., FACMG, President and Research Director, Van Andel Research Institute; President and Research Director, The Translational Genomics Research Institute (TGen)

 

The plenary began with each panelist introducing their background and key components of successful collaborations that each of their organizations had been able to forge. Highlights during this discussion were of successfully merging the business and science at the beginning of the process of collaborating, thereby gaining information from a wider-varied number of backgrounds, but at the same time making certain the partnerships that are being formed are strategically created for the work that needs to be done.


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CDER’s Efforts to Support Innovation in Regulatory Review and FDA Panel Discussion

November 21, 2011 at 9:55 AM by cdisc

Presentation by Dr. ShaAvhree Buckman, M.D., Ph.D., Director Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration

 

If there is something that clearly caught my attention during Dr. Buckman’s keynote speech is that FDA needs to have a standards-based environment, from end-to-end, to support a fully electronic receipt, review, and dissemination environment.

 

Dr. Buckman started her presentation talking about the current challenges for the 21st Century Drug Development.

 

Patients want the most up to date information on products and quickly, and this is only one part of an extremely complicated healthcare system. “The amount of time spent in the preclinical and clinical trials as well as the amount of time it takes for one FDA drug approval, involves tremendous effort, time and money!” Dr. Buckman stated.

 

She portrayed the current situation by providing an example of having “one New Molecular Entity” and explained that it will entail having over 9 gb of data and over 8.8 gb of documentation. She went on to mentioned that if the FDA receives a copy of a submission, that will require ~1.7 million pages, while if they have five copies then printed at FDA, they will need 8.5 million pages! The FDA spends a lot of money on paper, and solving this issue requires having some sort of electronic submission interface which will also certainly allow for greater efficiencies. We will have efficiencies if we have new ways to get eSubmissions; we can then improve regulatory decision-making through advanced analytics.

 

 


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CDISC Global Updates, Coordinating Committee Updates 12 October 2011

November 14, 2011 at 7:51 PM by cdisc

One of the most exciting components of the CDISC International Interchange is the session in which representatives from CDISC Coordinating Committees from around the world present on the progress that has been made throughout the past year.

 

Shannon Labout, Senior Director of Education for CDISC, opened the session and introduced the speakers:

 

• Rebecca Kush, CDISC President and CEO, speaking on behalf of Dr. Sukil Kim, Korea CDISC Coordinating Committee (K3C)

 

• Sheila Leaman, CDISC Manager of Global Relations, speaking on behalf of Simon Wang, China CDISC Coordinating Committee (C3C)

 

• Dr. Yoshio Tsukada and Hiroshi Azuma, Japan CDISC Coordinating Committee (J3C)

 

• Peter Van Reusel, speaking on behalf of Dr. Pierre-Yves Lastic, Europe CDISC Coordinating Committee (E3C)


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CDISC International Interchange Keynote: A Learning Health System

November 7, 2011 at 10:36 PM by cdisc

“I am going to talk about how CDISC and the work you are doing is already playing a role in the learning health system and may play an even greater role in the future,” said Dr. Charles Friedman in his opening keynote at the CDISC International Interchange.

 

Dr. Friedman cited the definition of a Learning Health System from the Institute of Medicine (IOM). A Learning Health System (LHS): …one in which progress in science, informatics, and care culture align to generate new knowledge as an ongoing, natural by-product of the care experience, and seamlessly refine and deliver best practices for continuous improvement in health and health care.

 

“In other words, it’s what your group does,” he stated. The vision would be nationwide safety surveillance with personalized medicine based upon research results upon which clinical decisions can be made--- not in the 17 years it currently takes, but in 17 months or 17 days(…or someday 17 seconds?)

 


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Virology Colloquium at the CDISC International Interchange 2011

November 3, 2011 at 12:05 PM by cdisc

The CDISC International Interchange 2011 was held again in the heart of Baltimore, MD at the Renaissance Harborplace Hotel, what an amazing location! The Interchange this year was quite rich of knowledge and information that many of you have missed if you could not attend. But, we are happy to share some of this information to keep you informed of our progress and to maintain your participation in our global mission, with a vision towards “Informing patient care and safety through higher quality medical research”. We are in a technology developing era that is fast-paced. Each day is a treasure for us to make use of the time towards the continuous progress of our CDISC projects. We are committed to utilizing our data standards wisely and efficiently for the humanitarian purpose of streamlining the development of cure for patients. During this year’s International Interchange, CDISC had a set of Colloquia sessions where many FDA folks were happy to be involved, providing their input on the work they do for the sake of patients and public health and how adopting the CDISC Standards ensures global consistency by avoiding errors and loss of time. The Colloquia was made possible by C-Path, ACRP & APPI.

 

 

  

 

The first colloquia session that I attended was on Tuesday, 11 October. It focused on the Virology domains and datasets. There was an FDA presenter, Helena Sviglin, who had drafted the initial Virology domains for comment. There were also 3 FDA reviewers attending this session, along with CDISC team members and experts from other organizations. Ms. Sviglin was happy to share the updates with us and was asking for comments from the attendees. She started off the session by telling us that they work with Dr. Chuck Cooper on validating data efforts of any of the review divisions; Dr. Cooper is an FDA reviewer, MD, in the Office of Translational Sciences, CDER, FDA.

 

 

 


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Metadata And SHARE Presentations - CDISC International Interchange 2011

October 27, 2011 at 1:45 PM by cdisc

I had the opportunity to attend Session 3 on the afternoon of 12 October at the CDISC International Interchange. This session included four presentations discussing Metadata and the CDISC Shared Health and Clinical Research Electronic Library (SHARE). The speakers and their specific topics were:

 


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CDISC Advisory Board Meeting with FDA Town Hall at the CDISC International Interchange

October 21, 2011 at 4:27 PM by cdisc

One of the greatest opportunities for CDISC Platinum Members attending the CDISC International Interchange is that, through their ability to have a seat on the CDISC Advisory Board (CAB), their representatives are invited to special events, such as the US Food and Drug Administration's (FDA) Town Hall Meeting that was held on the evening of Tuesday, 11 October. There was a fantastic turnout, and the hall was literally packed all the way to the doors with CDISC CAB members who came to pose questions to the FDA representatives.

 


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Exciting Buzz at the CDISC International Interchange in Baltimore on the Week of October 14

October 19, 2011 at 9:50 PM by cdisc

I sensed an exciting buzz at the CDISC Interchange in Baltimore this past week. On Wednesday afternoon, I attended Session 5, which was entitled “Standards “Up Front””. As a long time BRIDG Semantic Coordination Committee (SCC) member and liaison to the BRIDG Board, I was quite interested in the presentations from this session, which included topics such as the Protocol Representation Model (PRM), BRIDG, and the Study Data Model in XML (SDM-XML). [SDM = Study Design Model]

 

Starting with the last presentation first: Jan Kratky talked about CDISC’s brand new SDM-XML standard, which is posted on the CDISC website under Standards and Innovations. Jan mentioned that the SDM-XML addresses data about a study in the BRIDG “Planned” mode (which, of course, is much different from study data in the “execution” or “performed” mode). The standard addresses Study Design in 4 components: Study Summary/Inclusion Exclusion Criteria, Study Structure, Study Workflow, and Study Timing. The package also includes an example stylesheet for rendering the contents of an SDM-XML file. CDISC would like people to “kick the tires” of this standard and let us know about any improvements they would like to see.

 

 

Rich Gleeson gave the second talk, which was about using BRIDG as a foundation for e-clinical software integration. Starting with BRIDG as their conceptual model, they then created a logical model and then a physical model to support all applications. Yay! Model-driven architecture in practice! Based on BRIDG!

 

 

 

The first speaker, Gabriel Backianathan, talked about the PRM [CDISC’s Protocol Representation Model], and hopes that the Statistical Analysis Plan (SAP) will soon be added to that model. In fact, his wish will soon come true since we (the SCC) will begin harmonizing the Statistics Domain Analysis Model with BRIDG next week!

 

There will be more blogs coming about the Interchange, and we will keep you informed of the harmonization of the statistical aspects into BRIDG so that we can augment the Protocol Representation Model to include the SAP.

 

Julie Evans Sr. Director, Technical Services, CDISC


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CDISC International Interchange 2011 - Collaborating to Transform Health Care

October 17, 2011 at 5:48 PM by cdisc

If there is one theme that has come through loudly and clearly at the CDISC International Interchange in Baltimore last week, it is the theme of transforming clinical research and patient care through Collaboration.

 

Monday's keynote address introduced the concept of a distributed patient and research data sharing environment (similar to the internet) which could be used to significantly decrease the time it takes to get important safety, dosing or disease outbreak information back into the hands of clinicians at the point of patient care, thereby allowing clinicians to make well-informed patient care decisions.

 

 



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U.S. HIT Standards Committee – 28 September 2011

October 6, 2011 at 5:55 PM by cdisc

I was appointed to the U.S. Health Information Technology (HIT) Standards Committee, with ratification of this appointment in May of this year. This was just in time to observe “Summer Camp” activities and review the progress that committee had made since the time it was created (along with the HIT Policy Committee) in 2009. These achievements were particularly impressive when summarized at this 28 September meeting; they were acknowledged at a reception at the White House later that afternoon. Aneesh Chopra began the praise at this reception and continued to bring in a number of senior White House staff to reinforce their satisfaction with the productivity, civility and commitment of these two FACAs….”unprecedented” was the consistent underlying theme.

 

I had mixed feelings, having been too new to serve on the committees that had been formed prior to my appointment. I felt guilty to have been in the midst of those who truly deserved the praise. On the other hand, I felt pleasure that at least a couple of us from CDISC (Bron Kisler and myself) had given prior testimony to Task Forces of the HIT Standards Committee. I also felt fear and concern, hoping that the ‘train that has left the station’ has not already gone too far ahead for us to cleanly bring in the clinical research standards work that we have been doing for the past 14 years. Most of all, I felt opportunity…. that there is now an acknowledgement of the importance of global clinical research in this critical effort to encourage the adoption of EHRs across the U.S. and beyond. Many of the members of the HIT Standards Committee are well aware of the efforts of CDISC and of our willingness to collaborate, including two key players who have served on the CDISC Board of Directors.

 

Here are a few notes and quotes from the meeting that preceded the reception --- the culmination of “Summer Camp”--- during which friendship bracelets and whistles were distributed!

 


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Interoperability Town Hall and Showcase at the DIA in Chicago, IL

July 9, 2011 at 12:47 PM by cdisc

It has been said that “where fear is present, wisdom cannot be”. It is true that we do fear change thinking of the potential risks that it might hide, but no progress can be accomplished without change. It has never been easier for us -before now- where everything is automated and organized just the way we like it to be as in a futuristic motion picture! We did reach the day where with only one tap on our smartphones we can access email, get the latest bank statement and find the nearest restaurant not to mention that men have no quarrels on getting driving directions to find their way! Has this technology reached our healthcare system and medical records where we have one consolidated computerized source of information? I think we are on the right path! CDISC is the star leader in this domain, The Clinical Data Interchange Standards Consortium (CDISC) in collaboration with the Drug Information Association (DIA), Integrating the Healthcare Enterprise (IHE) and the Healthcare Information and Management Systems Society (HIMSS) has brought a state-of-the-art demonstration of the implementation of electronic health records (EHRs) to streamline medical research. This process represents a simple yet powerful means towards shortening the current 17 year gap in translating research results into clinical care decisions. This demonstration was presented at the DIA Annual in Chicago, IL on June 20 through June 22, 2011.

 

You will see more pictures from the showcase upon reading the full article.


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More on the Interoperability Town Hall from Landen Bain, the Primary Organizer of the Demonstrations

July 9, 2011 at 2:33 PM by cdisc

The HIMSS Interoperability Showcase at the DIA Annual meeting took place in Chicago the week of June 20, 2011. The CDISC blog already has three related posts, one from Diana and two from Becky on the Interoperability Town Hall. Now, as the primary organizer of the demonstrations, I’d like to add my perspective, but it might make sense to read the other posts first.

 

By most accounts, the Showcase was a success, with good traffic, enlightening demos, a central concept. At one point an attendee asked me a question which will provide the focus for this post: “what does it take to put something like this on?” To which I answered “oh, about 5 years”. No, I don’t mean that it took five years to organize this one event. But it is true that this Showcase was the culmination of five years (or more?) of effort under the heading of CDISC’s Healthcare Link initiative. During this initiative, CDISC reached across the divide between research and healthcare to engage with EHR vendors in the sister organization IHE. The Showcase demonstrated the results of this effort. Here’s what made it a success:


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More on the Interoperability Town Hall and Showcase at DIA 2011

July 8, 2011 at 6:33 PM by cdisc

My prior blog was based on notes that I took during the opening remarks from 5 FDA representatives and Dr. Fridsma of HHS/ONC, panelists at the DIA 2011 Interoperability Town Hall, which I moderated on 21 June. (If you did not read this one first, that would be recommended.)

 

After the Town Hall opening remarks, attendees from the audience asked questions of the panelists. I must admit that the questions surprised me---I had not anticipated the dichotomy. They fell primarily into two categories – 1) skepticism about using EHRs for research and the related regulatory constraints and data quality concerns; 2) requests from the audience participants to more broadly communicate the positive comments from the panelists to help move the use of EHRs for research forward. Clearly, there is more here than some may think….and by that I mean several things, which I will try to delineate further in this blog. [It did not help that some asked questions without having seen the Interoperability Showcase demonstrations. After being informed that they were missing at least half of the conversation if they had not seen the demo, it was reported that several went to see it the following day!]


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EHRs for Research---What do Representatives from FDA and HHS/ONC Think?

June 30, 2011 at 2:51 PM by cdisc

There was a whole new area in the DIA 2011 Exhibit Hall this year. CDISC announced, in a Press Release on 15 June, a partnership with IHE, HIMSS and DIA to bring the HIMSS Interoperability Showcase™ to DIA 2011 in Chicago. Not only were there a number of regulators who visited the demonstrations, but Terrie Reed of FDA CDRH participated in the showcase by demonstrating device safety reporting with EHRs as the source. Others demonstrated a process for using EHRs for clinical research. A Town Hall was held Tuesday afternoon to allow the regulators to express their reactions to the use of EHRs for research, particularly in light of the recent FDA draft guidance on eSource Documentation, and to allow the audience to ask them questions.

 

The Town Hall opened with each panelist providing brief remarks. I found these to be incredibly valuable, so I will do my best to recount the essence of at least some of what they said as accurately as possible (and will welcome their additional comments):

 

Dr. Leslie Ball, Director of the Office of Scientific Investigation (OSI), opened by asking the audience how many of them had navigated the DIA 2011 with the paper program? And, how many used the new DIA ‘Ap’ to navigate? And, how many had used both? She stated that this is an example of many of us who are caught struggling now between the two worlds – our paper past and the technology of the future. She commented that she now believes in EHRs, particularly since the site of her medical fellowship had converted to EHRs while she was there; this dramatically improved the availability of medical charts and x-ray images---suddenly they were all there, in the EHR system. No such seamless interface currently exists to get EHRs to communicate to the research world and Dr. Ball believes that we can get there. She stated that she would like to say we/FDA OSI support this effort, and she thanked CDISC folks for moving it forward. She feels it is a technical problem to be solved and closed by saying that it is only through the collective efforts of all in the room that we will solve it. Dr. Ball responded to questions from the audience about concerns on data quality in an EHR by asking back: “How do you assure the quality of the data in a paper medical record today?” She also commented that it would have been essentially impossible to falsify patient data in her experience with EHRs.


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CDISC Global Relations - Europe and Japan

June 16, 2011 at 10:03 AM by cdisc

In Europe, CDISC was invited to attend and present at the Knowledge Management Workgroup meeting of the Innovative Medicines Initiative (IMI) at the eHealth Week in Budapest (10-12 May).  There is an MOU in progress between IMI and CDISC that will relate to the use of CDISC standards, when available, for IMI Knowledge Management and partnering on new standards development as needed.

   Ann Martin of IMI


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Further CDISC Activities for 2011

June 16, 2011 at 10:08 AM by cdisc

More CDISC activities are already taking place in June…launching the CDISC summer in good form as we try to stay out of the Austin heat!   I hope that you don’t miss the DIA Annual meeting and, in particular the Interoperability Town Hall and demonstrations of EHRs as eSource for Clinical Research.  At the end of that, I will be heading for Washington, DC…. I am honored to have been invited by the Secretary of HHS and the new leader of the HHS/ONC to “represent research” as a new member on the U.S. HIT Standards Committee.   

  


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CDISC Global Relations - Global Standards Development

June 16, 2011 at 11:33 AM by cdisc

  

 

The Joint Initiative Council (JIC) and ISO TC-215 for Health Informatics met the week of 22 May in Kuopio, Finland. JIC is a collaborative initiative between 6 SDO organizations (CEN, CDISC, GS-1, HL7, IHTSDO and ISO), and is focused on Health Informatics Standardization. These organizations and their communities are bound together by a common purpose...Standardization across the healthcare spectrum that leads to interoperability between independent systems, enabling compatibility and consistency for health information and data while reducing redundancies and duplication of effort. Leading up to the meeting in Finland, there were 6 JIC projects approved for joint work and balloting:


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CDISC Spring 2011 – A Focus on Standards Progress

June 15, 2011 at 10:48 PM by cdisc

While the springtime was physically hot and dry in the southwest U.S. ---so much so that our normal Austin wildflowers were very sparse---there was a noticeable contrast in the CDISC spring activities!  There was so much going on for CDISC in April and May that it is difficult to know where to begin.  It makes sense to write several separate blogs that address the different areas of work CDISC staff and volunteers have been progressing for the past couple of months…since I wrote about the European Interchange.  I will begin with the standards development progress, then brief you all on the CDISC global relations and the activities within the global standards community that relate to medical research.

Progress continues within CDISC on the development of standards to support research in a number of therapeutic areas:   Pain/Analgesics (with the University of Rochester), Polycystic Kidney Disease (with Tufts University), Alzheimer’s Disease (with the Critical Path Institute), Oncology (with FDA and NCI), Cardiovascular Diseases (with ACC and Duke), Parkinson’s Disease (with C-Path and NINDS) and Tuberculosis (with the Gates Foundation and TB Alliance).   CDISC also responded to an FDA RFP for funds to continue Therapeutic Area Standards development. [Watch for the first TA “Package” on Alzheimer’s Disease coming soon.]   A presentation was made on the C-Path and Gates Foundation collaborations with CDISC (including progress on PKD, TB and Alzheimer’s standards and therapy development) at the Annual ACRP meeting in Seattle on 30 April.


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CDISC Global Relations - China

June 15, 2011 at 11:04 PM by cdisc

CDISC Global Relations in May included a very productive collaboration with the Drug Information Association (DIA) during their 3rd Annual Meeting in China in May.  The DIA kindly hosted a meeting of the CDISC China Advisory Committee (CCAC), which was launched by CDISC in Beijing in 2010 and is now chaired by Claire Tan of Quintlies (absent from the photo below as she is addressing the group at the front of the room).  Present were a number of experts in clinical research in China along with the DIA President of the DIA Board, the DIA Executive Director and representatives of the US National Cancer Institute (NCI) Julie Schneider (based in Beijing) and John Speakman (based in Rockville, MD).  

  

    Dr. Kush Meeting with the C3C


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Ann Martin of IMI Presented “The Role of Standards in Knowledge Management

May 19, 2011 at 6:51 PM by cdisc

 

 

 

 

Ann Martin of the Innovative Medicines Initiative (IMI) presented “The Role of Standards in Knowledge Management”, beginning with an overview of what IMI is and how they are involved:

 

• to promote knowledge creation, together with its disclosure and exploitation;

• to achieve fair allocation of rights;

• to reward innovation;

• to provide flexibility for participants to establish the most appropriate agreements serving the project objectives.

 

 

 

 


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Dr. Yoshio Tsukada, Leader of the J3C, Congratulated the E3C on their 10th Anniversary

May 19, 2011 at 7:39 PM by cdisc

In the final session of the CDISC European Interchange in Brussels on 14 April, Dr. Yoshio Tsukada, leader of the Japan CDISC Coordinating Committee (J3C) congratulated the E3C on their 10th Anniversary. The J3C started one year later, hence they will have their 10th Anniversary next year. Dr. Tsukada was the initial chair of the J3C and is once again the chair at this time; the J3C had an interim chair, Dr. Kiyoteru Takenouchi, who is now on the CDISC Board of Directors. Dr. Tsukada summarized the J3C and JUG (Japan User Group) activities over the past 9 years, including Interchanges and the fact that more than 300 Japanese have taken CDISC training courses on SDTM, ADaM, CDASH and other topics.

 

Shannon Labout and Rhonda Facile finished the presentations for the session with an update on CDASH. The new version is posted and new CDISC Education courses available.

 

To bring a great ending to the CDISC European Interchange, Dr. Pierre-Yves Lastic presented awards for the best poster and for a random drawing among CDISC Value surveys that were handed in by attendees.

 

 

 


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Dr. Steven Hirschfeld of NIH Presented at the CDISC Europe Interchange

May 2, 2011 at 1:18 PM by cdisc

Dr. Steven Hirschfeld, from the NIH National Institute of Child Health and Development (NICHD), is the leader of the U.S. National Children’s Study. He is also a director on the CDISC Board of Directors. Although he was a prominent contributor on Monday and Tuesday in Brussels at the CDISC Board meeting, he was required at meetings in the U.S. on Thursday and partnered with Bron to give his presentation at the Interchange. (Dr. Hirschfeld spent Wednesday in meetings at the European Commission in Brussels to partner with the EU on pediatric health initiatives). The key messages from Dr. Hirschfeld’s work include the importance of standards to ensure that data can be shared from ~ 100 sites using different technologies over the lifetime of a ‘child’ from infancy through age 21 and to accept these data into a common aggregated database.


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Bron Kisler, CDISC VP, Strategic Initiatives, Spoke at the CDISC European Interchange in Brussels

April 28, 2011 at 2:37 PM by cdisc

Bron Kisler (CDISC VP, Strategic Initiatives) spoke first at the Thursday (14 April) afternoon joint session of the CDISC European Interchange in Brussels. He emphasized the value for patients in adding standards specific to therapeutic area (efficacy standards) to the base CDISC standards (primarily the safety domains that are relevant to all clinical studies). He spoke of the need for inclusion of clinicians in developing definitions for these standard elements and also the value of having the viewpoint of the regulators who need to review application for new drugs in these areas. Specifically with respect to this latter viewpoint, one of the key benefits of standard cardiovascular elements is to simplify the analysis of events in drug development programs or among various clinical trials to more easily identify trends and other safety signals. CDISC began work on the cardiovascular data elements with Duke on an NIH Roadmap Grant several years ago. To augment this work, Dr. Karen Hicks of FDA initiated an effort that focused on the need for regulators to have standards to facilitate their reviews of new drug applications.


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Dr. Ilias Iakovidis was the Keynote Speaker for the CDISC European Interchange

April 22, 2011 at 10:22 AM by cdisc

Dr. Ilias Iakovidis was the keynote speaker for the Europe Interchange. He highlighted the work of the European Commission (EC), particularly with respect to eHealth. He spoke of the value of standards for interoperability and information re-use along with the lack of understanding and appreciation of this value in political circles. He encouraged the standards community to get involved at this level and to communicate in a comprehensible manner. He equated our current issues in healthcare to a ‘crisis’ and pointed to innovation as the way out of this crisis mode. He noted two key ‘goldmines’ that have not been appreciated adequately to date: Patients and Information. He also joked that if one cannot solve a problem, one can make it bigger! More seriously, he stated that solving some of the healthcare issues within a given country or even across the European Union did not seem to be working, so he began to work with the U.S. where the same issues exist. We can expect an announcement about the EC working with the U.S. Department of Health and Human Services Office of the National Coordinator (HHS/ONC) through a project called EPSOS to standardize EHR patient summary data for the EU and the US. Eventually, this should support public health research. The re-use of health data for public health, education and research is the goal. In this context, the EC is cooperating with HHS/ONC in two key areas: Interoperability and Exchange of Best Practices.


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Dr. Kush Presentation on how CDISC is Striving to Provide Value to its Broad Group of Members

April 21, 2011 at 9:06 AM by cdisc

During the CDISC European Interchange in Brussels last week, Dr. Rebecca Kush, President of CDISC, gave a presentation that focused on how CDISC is striving to provide value to its broad group of members. CDISC (unlike most standards organizations) offers its standards openly and freely. Standards development and maintenance, however, has associated costs. To cover these costs, CDISC continues to diversify its revenue streams such that funding now comes from many sources, including grants and contributions, in addition to education and membership. CDISC also has a range of members in various functional areas, which includes not only data managers, statisticians and IT professionals, but also medical writers and program/project managers. One important nuance is that CDISC retains the intellectual property (IP) for the CDISC standards so that it can ensure that they remain open and free. [Note that this is based upon negative experiences of other standards organizations who were hurt by not managing their IP appropriately. In fact, there is a CDISC IP Policy on the website under “About CDISC” –www.cdisc.org.]


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CDISC European Interchange, Brussels, Belgium, 13-14 April 2011

April 19, 2011 at 4:11 PM by cdisc

The CDISC European Interchange has taken place in the heart of Brussels, thanks to all who attended and made it successful! More than 200 people from all over the world attended this CDISC conference in Brussels, including more than 100 attendees for the training courses on Monday, Tuesday, and Friday. The CDISC Board of Directors also held a productive meeting in Brussels on 11-12 April to discuss CDISC Strategic Aims for the next five years.

 

Dr. Pierre-Yves Lastic, Chair of the European CDISC Coordinating Committee (E3C), opened the Interchange with a presentation on 10 years of CDISC in Europe. It was great to see the progress CDISC has made in Europe during this past decade. Many thanks for the hard work of the E3C and CDISC Operations.

 

Stay tuned to the next European Interchange blogs! These will be posted over the next two weeks. And get ready for the upcoming CDISC North America Interchange in Baltimore, MD on October 10 - 14.

 

Please consider a sponsorship or a booth and send in your abstracts; the deadline for submission is Friday, 6 May, 2011.


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Standards and the Patient - Dr Kush comments on the new stream at the North American Interchange

December 11, 2010 at 11:21 AM by cdisc

The second session on Thursday 4 November of the CDISC Interchange was comprised of four speakers who brought a true patient perspective and patient-oriented value to the picture of developing standards.  This session was chaired by David Handelsman of SAS, CDISC Advisory Board Representative to the Board Strategy Committee. 


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FDA Presentations & Panel from the North American Interchange

December 11, 2010 at 12:00 PM by newfangled

One of the traditionally popular sessions of the Interchange is the FDA Panel, which took place on Thursday, 4 November, in Baltimore.  In the prior session that afternoon, chaired by CDISC Technical Architect, Dave Iberson-Hurst, presentations were made by Dr. Vicki Seyfert-Margolis, Senior Advisor of Science and Technology, Office of the Commissioner; Amy Malla (CBER);  Dr. Chuck Cooper (CDER/Computational Science Center) and Dr. Steve Wilson (Biometrics, CDER).


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Final Notes from the North American Interchange by Dr. Rebecca Kush

December 11, 2010 at 12:11 PM by cdisc

Additional activities that took place at the Harborside during the week of 1-5 November included a meeting with FDA representatives to discuss ‘derived variables’ and how best to incorporate these into a submission, SDTM, ADaM...


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CDISC Operations and Education Update from the North American Interchange by Dr. Rebecca Kush

December 10, 2010 at 3:49 PM by cdisc

Frank Newby, CDISC Chief Operating Officer, provided an update this year, rather than having each team leader provide a separate presentation for their team’s update.  The rationale goes like this….. 


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The State of the CDISC Union: Creating Value and Ensuring the Future for CDISC by Dr. Rebecca Kush

December 9, 2010 at 6:32 AM by cdisc

“…..here’s the thing:   if I give my song away to 20 people and they give it to 20 people, pretty soon they know me and my value as a creator is dramatically enhanced.”
“The best way to raise demand for your product is to give it away.”

 

Both of these quotes, which I used to open my presentation at this year’s North American Interchange, were from John Perry Barlow--- the first as the lyricist for The Grateful Dead in the ‘70s and the second for Wired Magazine in 1994.


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2010 North American Interchange - Keynote Highlights by Dr. Rebecca Kush

December 7, 2010 at 3:50 AM by cdisc

Dawn over the Baltimore harbor was spectacular from the Renaissance Harborside. We are most grateful that our three keynote speakers were willing to drive into the city while the sun was yet rising to deliver a superb opening session to the CDISC Interchange.


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2010 North American Interchange - Highlights from Dr. Rebecca Kush

December 2, 2010 at 6:26 AM by cdisc

This year’s North American Interchange stood out for many as a high quality and informative event: “The Interchange this year provided a very positive environment.”  “The presentations were fresh and informative.” Just a couple of the comments we heard.


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Just Do It! Dave Iberson-Hurst reflects on the North American Interchange

November 16, 2010 at 5:29 AM by cdisc

It has been a week or so since I returned from the US Interchange and I thought it timely to write a short blog about the work that CDISC does and, more importantly, the people who, in the words of one rather well know sports goods manufacturer, Just Do It.


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Round Table Discussion Groups or How to Feedback your Experiences to CDISC - by Chris Decker

October 8, 2010 at 1:56 AM by cdisc

Chris Decker writes a guest Blog about the forthcoming Round Table Discussion Groups to be held at this year's North American Interchange. He explains who should attend and the importance of your input to the CDISC standards.


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Tagsdefine.xml, PRM, SDTM, Standards, ADaM, CDASH, ODM, Interchange,



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Paralysis and Madness: The Road to eSource Enlightenment by Dave Iberson-Hurst

August 24, 2010 at 11:58 AM by cdisc

Dave Iberson-Hurst discusses the evolution of the recently released EMA guidance on electronic Source Data and the challenges associated with developing new ideas.


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Japan, Part 3 of CDISC in Asia by Rebecca Kush

August 19, 2010 at 9:17 AM by cdisc

In the final part of Dr. Kush's blog series, she arrives in Japan for the Interchange to round off an exciting and demanding two weeks. 


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China, Part 2 of CDISC in Asia by Rebecca Kush

August 18, 2010 at 6:32 AM by cdisc

Yesterday, we posted Dr. Kush's experiences in Korea, today she and her two companions, Pierre-Yves Lastic and Sheila Leaman have reached China.  Here they meet with the CDISC China Advisory Council (CCAC), a new and important group. They also managed to visit one of China's most famous landmarks.


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CDISC in Asia - by Dr. Rebecca Kush

August 17, 2010 at 7:22 AM by cdisc

During the month of July, Dr. Rebecca Kush spent two weeks building CDISC's relationships with 3 very different countries and cultures in Asia. Accompanied by Pierre-Yves Lastic (sanofi - aventis) and Sheila Leaman (CDISC), Dr. Kush found that the work was inspiring and the sights stunning.

 

Over the next 3 days, you can read about CDISC's presence on the global stage, as Dr. Kush reports from Korea, China and Japan.


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CDISC SHARE – Progress Report by Rhonda Facile

July 5, 2010 at 8:54 AM by cdisc

By now, many of you have heard about the CDISC SHARE project.  For those of you that haven’t,   this new initiative seeks to develop multi-dimensional, machine-readable clinical study metadata that is based on ISO data standards and the BRIDG model. In short we want to change the way we develop standards to an approach that focuses on precise definitions, terminology and metadata (BRIDG, datatypes, variable names, etc.) to take a date element/concept from the clinical protocol, through collection, analysis and submission.  To quote Dave Iberson-Hurst, CDISC is, “moving from the implicit world of data standards to the explicit world of data standards”.


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FDA, CDISC Standards and the Critical Path by Rebecca Kush

June 29, 2010 at 2:54 PM by cdisc

June has been a month full of interesting meetings, events and activities for CDISC.  In particular, Bron Kisler and I attended a set of meetings in the Washington, DC area 8-11 June while others within CDISC met face-to-face in Philadelphia to advance the CDISC SHARE project. 


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The Critical Path to TB Drug Regimens (CPTR) by Bron Kisler

June 29, 2010 at 3:08 PM by cdisc

The Critical Path to TB Drug Regimens (CPTR) is a recently formed collaboration of global pharmaceutical companies; government and regulatory agencies; foundations and donors; academia; and patient advocacy groups. The CPTR initiative was created and is managed by a partnership of the Bill & Melinda Gates Foundation, the Global Alliance for TB Drug Development (Global TB Alliance) and the Critical Path Institute (C-Path).


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FDA CDER Data Standards Plan V 1.0 and PDUFA IV IT Plan Update Released By Dr. Rebecca Kush

June 28, 2010 at 4:51 AM by cdisc

Two new documents relevant to CDISC have now been posted to the FDA website and one announced in the Federal Register.  In this blog are a few highlights that I have pulled from each of the documents…but, please read them yourselves and  please sign up to attend the webinar on 29 June to hear directly from CBER and CDER representatives, Amy Malla and Dr. Chuck Cooper.


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TagsCDASH SDTM, CBER, FDA, PDUFA, Standards, ODM, CDER,



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Important BRIDG News and an Update from the ISO Meeting

May 19, 2010 at 2:06 PM by cdisc

CDISC co-sponsored and participated in the ISO TC-215 meetings this past week in Rio de Janeiro, Brazil. It was an amazing week with Dr. Christopher Chute assuming the helm of ISO TC-215 Health informatics as Chairperson. It was a productive week for CDISC with positive movement on many fronts. The week began with a CDISC presentation to international delegates from Brazil, Singapore and Australia ...


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Dr Rebecca Kush - Reflections on an excellent Interchange

May 18, 2010 at 6:16 AM by cdisc

Reflecting on the recent European CDISC Interchange, the phrase that reverberates in my mind is “Standards Everywhere”.  This is a credit to Dr. Paul Avillach, who asked to use my camera on Friday evening as half a dozen of us (who stayed through the bitter end to teach or participate in the CDISC Healthcare Link Course and the CDISC-HL7 Tutorial) ...


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Dr Rebecca Kush - Voices from the CDISC FDA Town Hall Meeting

March 30, 2010 at 4:37 PM by cdisc

The CDISC INTRAchange was launched this year on the evening of 23 March, following the DIA FDA CDER/CBER Computational Science Annual Conference, with a CDISC FDA Town Hall Meeting.  Frank Newby welcomed everyone and introduced the FDA representatives ...


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An Update from London and the European Interchange

March 11, 2010 at 6:11 AM by cdisc

As part of my job for CDISC, I am privileged to work with the European CDISC Coordinating Committee (E3C) on the Interchange in Europe. This has a few wonderful perks. Firstly, I get to see the hotel and the evening event location before all of the attendees and most of the CDISC staff and secondly I spend a day with Dominik Ruisinger (who many of you will know), thrashing out the details.


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Landen Bain - Healthcare Link Updates

February 17, 2010 at 8:00 AM by cdisc

Landen went to Phoenix AZ for the first IHE face-to-face meeting of 2010.  The four day meeting was particularly productive. CDISC participates in the Quality, Research, and Public Health (QRPH, rhymes with Smurf) domain. The integration profiles under development that directly influence CDISC’s Healthcare link initiative are Retrieve Protocol for Execution (RPE) and Redaction Services. QRPH schedules its face-to-face meetings with two other IHE domains (there are 14 in all): Information Technology Infrastructure (ITI) and Patient Care Coordination  (PCC)...


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Clear Messages from FDA CDER and CBER

February 10, 2010 at 7:26 AM by cdisc

by Dr. Rebecca Kush

There are some very clear messages coming from FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER).  As of a meeting with CDER and CBER Representatives and the CDISC Executive Committee on 1 February ....


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Reasons to Celebrate - The Protocol Representation Model

February 8, 2010 at 4:26 AM by cdisc

Diane Wold of GSK gives her personal insights into the Protocol Representation Model

Those of us who started working toward a structured protocol representation in 2003 were motivated by the feeling that there had to be a better way to communicate information about a study than a text document.  The protocol is at the heart of clinical research, so it's just not effective or efficient for all the parties involved to extract data from text ...


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Protocol Representation Model V1.0 - Now Released!

February 1, 2010 at 8:07 AM by cdisc

The CDISC Protocol Representation Model (PRM) Version 1.0 is released and available at http://www.cdisc.org/protocol.

The Model contains study protocol concepts such as Trial Design, Eligibility Criteria, and addresses the requirements from the ClinicalTrials.gov and World Health Organization (WHO) registries.  Additional protocol domain areas, activities, definitions ...


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Rebecca Kush - FDA Messages from the Interchange: Use CDISC Standards Now

December 1, 2009 at 9:08 AM by cdisc

In the prior CDISC Blog, Dave Iberson-Hurst explored the ‘disappearing’ timelines for the HL7 transport mechanisms for CDISC content.  Since these HL7 standards (which by the way will be co-owned by CDISC and HL7 if and when they are ready) are not yet available nor tested, what does FDA want to see now (TODAY) when it comes to data standards? ...


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The FDA, HL7 and a Disappearing Timeline

November 19, 2009 at 8:38 AM by cdisc

It might not have been a presidential debate but the closing session at the North American Interchange was no less intriguing. The session was an FDA panel that opened with a speech from the FDA Deputy Commissioner Dr Sharfstein ...


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Landen Bain - Healthcare Link, More than Learning ...

November 18, 2009 at 9:17 AM by cdisc

Fifteen attendees and presenters spend Friday the 13th teaching, learning, and sharing concepts around CDISC’s healthcare link project.  This is the second time that CDISC has presented a training session on healthcare link, the first being at the Japan Interchange in July of this year ...


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An evening with the Sharks!

November 12, 2009 at 2:30 PM by cdisc

The CDISC Interchange rounded off the first day with an evening social event at the National Aquarium. And what an event it was, with the food and beverages organised across the various levels of the aquarium, attendees were able to see a variety of interesting animals, including sharks, rays and a fantastic jellyfish exhibit.

Rather than write about it ... take a look at the wonderful photos taken by Pierre-Yves Lastic.

 


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Interoperability ... the Value of Standards - Live from the CDISC Conference

November 11, 2009 at 10:29 AM by cdisc

The CDISC conference is underway with the opening session and whilst the presentations were diverse, all of the speakers emphasised the importance of standards and the value they bring to medical research ...

 


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Rebecca Kush: Live from the Conference - the Global Update

November 11, 2009 at 12:26 PM by cdisc

Dr. Rebecca Kush gave a compelling and engaging update on CDISC's global activities over the past year. Firstly, she thanked the members of the CDISC Advisory Board (CAB) who had developed the program for this year's conference and highlighted the new demonstrations that are taking place in the exhibition area during the event ...


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Landen Bain - Awards, Phenotypes and EHRs, all in a day's work.

November 10, 2009 at 3:36 PM by cdisc

The NIH sponsored symposium "Widening the use of EHR data for Clinical Research" took place on October 30, at the end of the Clinical and Translational Science Awards (CTSA) face-to-face meeting on the NIH campus in Bethesda, MD.  NIH manages forty-six awards in this program, and the CTSA sites represent a cross-section of the high-end academic medical centers in the US. So a face-to-face meeting of CTSA sites brings together a broad spectrum of academic medical center informatics types ...


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Chris Tolk, Reports from FDA at White Oak

November 6, 2009 at 8:57 AM by cdisc

I attended the Coalition Against Major Disease (CAMD) Coordinating Committee Meeting at the FDA’s White Oak Campus this week. The initial goal of CAMD is to define clinical data standards and establish a pooled database of the control group of pharmaceutical clinical trials in order to develop quantitative disease progression models for both Alzheimer’s and Parkinson’s disease ...


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Tagstherapeutic, alzheimer's, CDISC, SDS CDER, FDA,



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Rebecca Kush, CDISC & the Standards Landscape

November 5, 2009 at 5:57 AM by cdisc

ISO Pic

The International Standards Organization (ISO) recently held one of its twice-yearly meetings in Durham, North Carolina. Past meetings CDISC attended were in Istanbul, Turkey; Goteborg, Sweden; Edinburgh, Scotland. Here you can see one of the banners at the Durham meetings, thanks to Bron Kisler for the photo...


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Rebecca Kush, 'What is a Standard?'

November 4, 2009 at 4:12 AM by cdisc

The HHS Workshop on 15 October was entitled “Identifying Opportunities to Maximize the Utility of Genomics Research Data Through Electronic Health Information Exchange”.  Notice that the word “Standard” is not mentioned; this was intentional.  Some of you may ask why?  
I have been informed many times that the word ‘standard” connotes such ideas as rigidity, stifling creativity, inhibiting innovation. There are indeed many different types of standards (from a sort of flag, to a type of rather mundane beef to a standard operating procedure)...


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Rebecca Kush, Bringing the Puzzle Together

November 3, 2009 at 12:07 am by cdisc

November is suddenly upon us and I am wondering where the first 10 months of the year have gone. While welcoming the earlier sunrise (and the end of daylight savings, which brings no favors to those of us who live in the hotter areas nearer the equator), there is reason to reflect on what CDISC has done in the past 10 months of 2009 and where we are going in 2010. There have been many opportunities to do this recently...


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Landen Bain - Reports from Under the Deliverables Mountain!

October 28, 2009 at 9:53 AM by cdisc

Poor Landen is in over his head this month with three deliverables hitting at the same time: HITSP IS 158, CCHIT clinical research criteria, and IHE Redaction Services proposal all due the last week of October.  That’s this week!  So what do these deliverables mean for CDISC?  Here’s a sketch, with more to follow ...


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Consensus through SHAREing!

October 27, 2009 at 5:09 PM by cdisc

Since I last wrote on the blog much has changed. As you may have noticed, we have a new website. This has taken a great deal of effort by the CDISC communications staff to get this developed and the content from the old site moved across. It took a little longer to get the blog up and running as part of the new site but we are there now.


The other day, I looked at one of my computer screens. My twitter feed started reporting...


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Julie Evans at ISO in North Carolina

October 21, 2009 at 6:10 AM by cdisc

I’m just back from the ISO TC 215 Joint Working Group meeting in Durham, North Carolina.  I was there to give a BRIDG update to Working Groups 1 and 2.  The update included a quick BRIDG status, a review of the New Work Item Proposal (NWIP) results  for BRIDG (it passed in August 2009), and the plans for the upcoming ballot through the Joint Initiative Committee (JIC) process.  The group voted to propose  a resolution to the plenary to ballot BRIDG.  So, we’re making progress in our effort to make BRIDG a global, open, publicly available standard.


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Tags215, JIC BRIDG, ISO, TC



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The Impact of Shared Semantics

June 11, 2009 at 6:21 AM by cdisc

Last week, I had just returned from San Francisco after a face-to-face meeting about the CDISC work to build a repository of shared semantics. After a long trip home, I indulged in my interest in cycling and caught up with the Tour of Italy, the Giro d’Italia. The Giro, along with the Tour of Spain – the Vuelta – and the Tour de France are the three premier events on the annual cycling calendar. This year was the 100th running of the Giro and, after being out of professional cycling for three years, Lance Armstrong was competing in the event for the first time. Lance was there to raise awareness of his Livestrong charity and its work in fighting cancer. With Lance at the event the media interest exploded....


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Tagssemantics, metadata CDISC SHARE, shared



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One Man's Metadata is ...

March 16, 2009 at 6:03 AM by cdisc

One of the main reasons for starting the CDISC blog was to improve the flow of communication from CDISC to the CDISC community. It is a feature of CDISC that the less we communicate the better the quality of the rumours. The problem we face is that however much we do actually communicate, we could always do more. This has certainly be true when I think about the CDISC HL7 project and some of the rumours that surround that work. However, more about that project in a later post ...


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Tagsmetadata, SHARE,



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