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CDISC in Japan

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.

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

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!

Computational Science Symposium, Silver Spring, MD

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.

EHR Roundtable Meeting

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.

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

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.

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

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.

Partnering for Cures: A FasterCures Meeting

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.

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

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.

CDISC Global Updates, Coordinating Committee Updates 12 October 2011

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)

CDISC International Interchange Keynote: A Learning Health System

“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?)

Virology Colloquium at the CDISC International Interchange 2011

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.

Metadata And SHARE Presentations - CDISC International Interchange 2011

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:

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

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.

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

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

CDISC International Interchange 2011 - Collaborating to Transform Health Care

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.

U.S. HIT Standards Committee – 28 September 2011

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!

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

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.

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

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:

More on the Interoperability Town Hall and Showcase at DIA 2011

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!]

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

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.

CDISC Global Relations - Europe and Japan

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.

Further CDISC Activities for 2011

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.   

CDISC Global Relations - Global Standards Development

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:

CDISC Spring 2011 – A Focus on Standards Progress

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.

CDISC Global Relations - China

CDISC Global Relations in May included a very productive collaboration with the Drug Information Association (DIA) during their 3^rd 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).  

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

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.

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

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.

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

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.

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

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.

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

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.

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

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.]

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

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.

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

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. 

FDA Presentations & Panel from the North American Interchange

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).

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

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...

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

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….. 

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

“…..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.

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

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.

2010 North American Interchange - Highlights from Dr. Rebecca Kush

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.

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

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.

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

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.

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

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

Japan, Part 3 of CDISC in Asia by Rebecca Kush

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. 

China, Part 2 of CDISC in Asia by Rebecca Kush

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.

CDISC in Asia - by Dr. Rebecca Kush

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.

CDISC SHARE – Progress Report by Rhonda Facile

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”.

FDA, CDISC Standards and the Critical Path by Rebecca Kush

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. 

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

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).

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

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.

Important BRIDG News and an Update from the ISO Meeting

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 ...

Dr Rebecca Kush - Reflections on an excellent Interchange

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) ...

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

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 ...

An Update from London and the European Interchange

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.

Landen Bain - Healthcare Link Updates

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)...

Clear Messages from FDA CDER and CBER

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 ....

Reasons to Celebrate - The Protocol Representation Model

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 ...

Protocol Representation Model V1.0 - Now Released!

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 ...

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

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? ...

The FDA, HL7 and a Disappearing Timeline

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 ...

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

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 ...

An evening with the Sharks!

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.

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

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 ...

Rebecca Kush: Live from the Conference - the Global Update

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 ...

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

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 ...

Chris Tolk, Reports from FDA at White Oak

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 ...

Rebecca Kush, CDISC & the Standards Landscape

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...

Rebecca Kush, 'What is a Standard?'

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)...

Rebecca Kush, Bringing the Puzzle Together

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...

Landen Bain - Reports from Under the Deliverables Mountain!

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 ...

Consensus through SHAREing!

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...

Julie Evans at ISO in North Carolina

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.

The Impact of Shared Semantics

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....

One Man's Metadata is ...

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 ...