11:00-12:30 PM ET

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.

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!

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.

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.

The CDISC May Newsletter Presents the Following Topics:

• CDISC International Interchange 2013 - Call for Abstracts!
• CDISC 2012 Annual Report
• CDISC Success Story: A Cytel Case Study: The Use of CDISC Standards in Unilever's Cosmetics and Food Products Trials 
• Read our Blogs on the success of the CDISC European Interchange in April 2013 in Bad Nauheim, Germany and at the Partnerships Conference in Orlando:

1. CDISC Europe Interchange 2013 - Very Pleasant Start
2. A Flavor of the CDISC Europe Interchange
3. The Tenth CDISC European Interchange - An Outstanding Experience
4. Notes from Partnerships in Clinical Trials

• CDISC Technical News
• CDISC Foundational Standards (CDASH, SDTM, ADaM) in Chinese version are released for public review
• CDISC Advisory Council Call for Nominations
• CDISC Members Updates
• Formedix to Host Executive Breakfast Focused on CDISC Standards Implementation prior to Bay Area CDISC Network Meeting, on 23 May 2013
• CDISC User Networks - CDISC Bay Area User Network Meeting and CJUG Updates
• Job Opportunities within CDISC
• Opportunity to Donate to CDISC 
• CDISC Volunteer Opportunity
• Global Events and Education Opportunities
• CDISC Official Primer for a Lower Price 
• CDISC Social Media

Join us at the CDISC International Interchange in Bethesda, MD on 4-8 November 2013

"SHAREing Data: Data is Meaningless unless it's SHAREed" is the theme of the CDISC International Interchange 2013. Join us at this event and stay abreast of the latest achievements and updates from CDISC. Hear from experts and leaders of healthcare who will be available to provide feedback and share experiences with the audience. This year's International Interchange will be unique, watch the CDISC website for details on the program and please consider submitting an abstract if you have a case study to share with others.

CDISC is now accepting abstracts on case studies that include metrics on utilizing the CDISC standards. Click here to submit an abstract. The deadline for abstract submission is 16 July 2013.

Increase the global awareness of your organization's mission and goals by sponsoring and/or exhibiting at our interchanges.

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CDISC 2012 Annual Report

Focused around the central theme of Teamwork, CDISC is proud to announce the release of the 2012 Annual Report. Features include a 2-page spotlight on our CDISC Teams and the efforts that they have made in standards development during 2012, as well as our Global Organization and the way in which different groups within CDISC interact with each other. Also included are 2012 Milestones, 2012 Collaborations, and updated information on our success in the areas of CDISC Education, Membership, Communications, and an overview of our Financials. Also, don't forget to check out our "Team Roster" on the back page to see your organization's name listed and to find out how long each member organization has been a supporter of CDISC! If you should have any questions regarding the 2012 Annual Report, please do not hesitate to email Andrea Vadakin, CDISC Manager of Public Relations at avadakin@cdisc.org. Click here to view the CDISC 2013 Annual Report.

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CDISC Success Story

In an attempt to increase value for its stakeholders, CDISC initiated the feature of Success Stories in 2012, and we are continuing these in 2013. These stories reflect experiences with the CDISC standards and how they bring success and add efficiency to the work environment. If you would like to present your success story with CDISC in a future Newsletter, please contact Diana Harakeh. This month, we will feature Cytel with a case study about their implementation experiences with the CDISC standards for cosmetics. In addition, see the blogs below for a summary of our successful 2013 CDISC European Interchange, which was recently held in April in Bad Nauheim, Germany and a summary of our experiences at the concurrent Partnerships Conference in Orlando.

A Cytel Case Study: The Use of CDISC Standards in Unilever’s Cosmetics and Food Products Trials

Cytel is a technology services provider that develops statistical software, clinical trial programming and analytic services. The company has extensive experience in clinical development and expertise in biostatistics, operations research, SAS programming, medical writing, data management and software development, and is a leader in the design and implementation of adaptive clinical trials.

With experience migrating over 150 studies as part of 20 U.S. Food and Drug Administration (FDA) submissions, Cytel’s CDISC Implementation Team efficiently develops CDISC SDTM and ADaM data sets that are compliant with required guidelines. The CDISC Implementation Team is comprised of expert programmers and statisticians that understand the analytical requirements of complex trials and have extensive experience preparing data for submissions to regulatory authorities. All studies in which Cytel has led migration and submission to the FDA have been accepted. Click here to view the full article.

CDISC Europe Interchange 2013 - Very Pleasant Start (by Diana Harakeh)

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.

Click here to read more.

A Flavor of the CDISC Europe Interchange (by Dr. Rebecca Kush)

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. 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! Click here to read more.

The Tenth CDISC European Interchange - An Outstanding Experience (by Diana Harakeh)

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. Click here to read more.

Notes from Partnerships in Clinical Trials (by Andrea Vadakin)

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. Follow the link to read more.

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Follow the link for standards open for review and comment as well as new standards available for use. Stay tuned to our homepage for details on Standards and Technical updates as well as current CDISC information.

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Join us for our monthly webinars to hear the latest updates and achievements on the CDISC standards. Click here to view the scheduled webinars in 2013.

Our next webinar is scheduled on 6 June 2013. Click here to see more details on the topics and registration information.

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CDISC Foundational Standards (CDASH, SDTM, ADaM) in Chinese version are released for public review

The China CDISC Coordinating Committee (C3C) and CDISC Standards Translation and Review (C-STAR) project team are pleased to announce the release of CDASH (v1.1), SDTM (SDTM v1.2 /SDTMIG v3.1.2) and ADaM (ADaM 2.1 /ADaMIG 1.0) for public review after 2 years of effort. (See below for the Chinese version of this announcement).

C-STAR was setup in May 2011 to review the Chinese translation of CDISC Foundational Standards which were provided by Absolute Systems Clinical Data Co., Ltd. All participants are volunteers from CRO, pharmaceutical companies and academia who are CDISC standard experts or practitioners experienced in this area. In order to ensure the highest quality of the translation and the adherence to the original English version, a very strict translation process was developed: translation, editing, proofreading, review and then cross review.

CDISC Foundational Standards provide the basis for the complete CDISC suite of standards, supporting the clinical research process from protocol through data collection, data management, data analysis and reporting. The Clinical Data Acquisition Standards Harmonization (CDASH) Standard defines basic standards for the collection of clinical trial data. The Study Data Tabulation Model Implementation Guide for Human Clinical Trials (SDTMIG) is intended to guide the organization, structure, and format of standard clinical trial tabulation datasets submitted to a regulatory authority such as the US Food and Drug Administration (FDA). The SDTMIG should be used in close concert with the current version of the CDISC Study Data Tabulation Model (SDTM) that describes the general conceptual model for representing clinical study data that is submitted to regulatory authorities. The ADaM document explains the purpose of the Analysis Data Model. It describes fundamental principles that apply to all analysis datasets, with the driving principle being that the design of analysis datasets and associated metadata facilitate explicit communication of the content of, input to, and purpose of submitted analysis datasets. The Analysis Data Model supports efficient generation, replication, and review of analysis results.

The translation of CDISC standards is expected to greatly increase CDISC awareness in China clinical research industry, including academia and regulatory agencies. In addition, C3C and C-STAR are making every effort to introduce and facilitate CDISC standards into practice in China, so China can gradually improve the data quality of clinical trials and play a more important role in the global clinical research environment.

Please note that comments are being requested on the translation into Chinese, NOT on the standards themselves.

CDISC基础标准（CDASH，SDTM和ADaM）中文版发布征集意见稿 中国CDISC协调委员会（C3C）与CDISC标准翻译审阅（C-STAR）项目组很高兴宣布：经过两年的努力，CDASH （v1.1），SDTM（SDTM v1.2/SDTMIG v3.1.2）和 ADaM （ADaM v2.1 /ADaMIG v1.0)中文版征集意见稿发布了。 C-STAR成立于2011年5月，以审阅CDISC基础标准（CDISC Foundational Standards）的中文翻译初稿。这些初稿由北京阿贝斯努信息技术有限公司（Absolute Clinical Data Systems Co., Ltd）提供。所有参与的志愿者均来自CRO、制药企业或学术界中的CDISC标准的专家及在该领域有丰富经验的从业者。为了确保最高的翻译质量，并忠于 英文原版，C-STAR项目组制定了一套非常严格的翻译流程：翻译，编辑，校对，审阅，然后交叉审阅。 CDISC基础标准（CDISC Foundational Standards）提供了CDISC全部配套标准的基础，支持临床试验的全过程：从方案设计到数据采集、数据管理、数据分析及报告生成。临床数据获取标 准（CDASH）定义了临床数据采集的基本标准。临床试验中研究数据列表模型实施指南（SDTMIG）意在指导递交给监管机构，如美国食品药品管理局 （FDA）的标准临床试验列表数据集的组织、结构及格式。在使用SDTMIG时应紧密参照当前版本的CDISC研究数据列表模型（SDTM），该模型描述 了用于递交给监管机构的临床研究数据所需应用的通用概念模型。分析数据模型（ADaM）文档解释了分析数据模型的目的，描述了适用于所有分析数据集的基本 原则。其驱动原则是，分析数据集与其关联的元数据的设计，能够促进对递交的分析数据集的内容、来源、和目的的清晰理解。利用ADaM可以高效地生成、再 现、审阅分析结果。 CDISC标准的中文版的翻译将能在中国临床研究领域，包括在学术界和监管机构，扩大CDISC的知晓度。另外，C3C和C-STAR将不遗余力地介绍和 促进CDISC标准在中国的应用，以使中国可以逐渐改善临床试验数据的质量，并在全球临床研究领域扮演更重要的角色。 请于2013年7月8日之前，将您的建议使用如下CDISC收集建议模板发回给我们。

Click here to view the standards for review. 

Please send your comments by 16 July 2013 using the CDISC comment templates below:

1. Comment for ADaM
2. Comment for SDTM
3. Comment for CDASH

Please send your comments on these Chinese versions of CDISC standards to info@cdisc.org.

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CDISC Advisory Council Call for Nominations

The CDISC Advisory Council (formerly known as the CDISC Advisory Board) is now requesting nominations for Chair-elect of this Council. Please submit your qualified nominations (which must be from CDISC Platinum Member Organizations) to Sheila Leaman (sleaman@cdisc.org) no later than 16 July 2013.

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CDISC Members Updates

New Gold Members in April:

• XOMA - USA
• Cognitive Research Corporation - USA

Thank you and a warm welcome to our new members in April. The CDISC community continues to grow and we encourage you to reach out and connect with fellow members and CDISC staff via the various forums provided by CDISC Communications.

Star Members in May:

5 years with CDISC:

• Syne qua non, Ltd. - UK
• Asklep, Inc. - Japan

10 years with CDISC:

• Medidata Solutions, Inc. - USA
• XClinical - Germany

Click here to see our STR MEMBERS

Non-Members can enjoy all our benefits and more by joining CDISC! Please contact membership@cdisc.org for further details.

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Formedix to Host Executive Breakfast Focused on CDISC Standards Implementation prior to Bay Area CDISC Network Meeting, May 23, 2013

Formedix, a leading provider of CDISC based clinical trial automation software and consultancy services, is hosting an executive breakfast on May 23, 2013 from 9 am, prior to the Bay Area CDISC Network Meeting, which will also be sponsored by Formedix. The event is being held in the South San Francisco Conference Center. Mark Wheeldon, of Formedix, will be joined at the morning event by CEO of CDISC Rebecca Kush and David Borbas, Senior Director of Data Management at Jazz Pharmaceuticals for presentations celebrating CDISC standards and their use within the clinical trial process. The breakfast will provide attendees with the opportunity to hear the opinions of industry specialists on CDISC standards and their application throughout a clinical trial and to enjoy high-level networking. Click here to view the full press release.

Register here if you would like to attend the Executive Breakfast meeting.

And see the User Network section below if you are interested in attending the Bay Area User Network meeting on 23 May 2013.

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CDISC User Networks

CDISC User Networks have been formed all around the globe in Africa, Asia, Europe and the United States of America. User Networks enable face-to-face interactions to encourage the adoption of CDISC standards by sharing implementation experiences in various global communities and regional areas. They play an essential role in expanding the CDISC international presence.

CDISC Bay Area User Network Meeting on 23 May 2013

The CDISC Bay Area User Network meeting will take place on Thursday, 23 May 2013 from 12:30 PM to 4:30 PM at the South San Francisco Conference Center (at the same location where the Formedix CDISC Executive Breakfast meeting will be held on 23 May 2013). If you would like to join this meeting, please reply to this e-mail (jbrega@pharmastat.com) to help us get an accurate count for planning purposes. Attendees are advised to arrive early to find a parking spot. The room will be open at 12:30 PM and the meeting will start at 1:00 PM. If you cannot attend in person, you have the option of joining the web conference meeting. A meeting link and teleconference number are provided through the following link. Click here for agenda details, directions and web conference information.

The CDISC Japan User Group Recent Meetings and Updates (by Yoshiteru CHIBA)

Recently held meetings:

The CDISC Japan User Group (CJUG) hosted a CDISC SDTM team meeting on Friday, 12 April 2013 at Dainippon Sumitomo Pharma Co., Ltd in Tokyo, Japan where 30 people attended this event. The conference started with an online presentation: "About PhUSE" provided by Mr. Senk Frank. During the second session, the team discussed the SDTM data implementation updates. And the last session was concluded with a presentation by Mr. Takashi MISAWA of ACRONET Corporation. Mr. MISAWA who is a member of LISaS (an SDTM Sub-Team) presented on the “SDTM Filesize Issue Updates”.

Another CJUG SDTM team meeting was held on Friday, 10 May 2013 at The Institute of Japanese Union of Scientists & Engineers (I-JUSE) in Tokyo where 32 people attended this conference.

Recently, four new members have joined the CJUG team:

• Mr. Yutoku KITAHARA of Bell Medical Solution Inc.
• Mr. Hideharu YOKOMACHI of Bell Medical Solution Inc.
• Ms. Hanae UEYAMA of Kyoto University Hospital
• Ms. Mariko DOI of Kyoto University Hospital

Various presentations were provided throughout the meeting on 10 May, among which was a talk by Dr. Hideto YOKOI of Kagawa University Hospital Department of Medical Information. Dr. Hideto presented through an online webinar as he was on a business trip in the U.S. attending a meeting with the U.S. Food and Drug Administration. His presentation topic was "Challenge of linking EHR to EDC". During the second session, the team discussed the SDTM data implementation latest updates. The topics included creating a CRF sub-group, creating a Trial Design Model sub-group, EDC Builder sub-group and Protocol sub-group.

Upcoming CJUG meetings:

The next CJUG SDTM Team meeting will be held on 14 June 2013 at the University of Tokyo. The meeting is scheduled from 13:00 to 17:00. During this conference, the SDTM data implementation activity sub group will discuss creating a CRF sub-group, EDC Builder sub-group, Trial Conductor sub-group and study reviewers guide sub-group. In addition, a presentation on “About next eCTD” will be provided by Ohbayashi. Furthermore, another talk about “VISITNUM/VISIT -SV vs. Other Domain-“ will be provided by Mr. OHNO of CHUGAI clinical research center CO, LTD. Mr. OHNO is a member of LISaS which is an SDTM sub-team.

To join a CDISC User Network, contact Diana Harakeh. The User Network portal area is open to anyone and provides information on specific User Networks, including announcements of their next meetings.

Follow the link to know more about the purpose and benefits of the CDISC User Networks.

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CDISC Job Opportunities Available

CDISC is seeking candidates for two current job openings:

1. SHARE Project Manager: this position will be responsible for implementing the SHARE metadata repository system and managing ongoing SHARE operations. Candidates should be familiar with CDISC standards, clinical research data and have experience implementing information systems projects.
2. Terminology Specialist: work with our NCI EVS partners and CDISC controlled terminology, foundational standards and therapeutic area teams to develop controlled terminology for CDISC standards.
3. CDISC Software Applications Specialist: this position will ideally be based in Austin, TX. Please contact Julie Evans at jevans@cdisc.org and mention the CDISC eNewsletter if you are interested in learning more about this position.

Donate to CDISC  

The U.S. Internal Revenue Service (IRS) approved CDISC as a 501(c)(3) organization in December 2011, recognizing it as a charitable organization retroactive to May 2011.

With our current ability to receive tax-deductible contributions from individual and corporate donors, we will promote CDISC’s message to a broader audience, enhancing CDISC’s capacity to locate funds through diverse means. Your contribution will help us accelerate the availability of new medical therapies to patients in need. Follow the link to know more about how to make your valuable donation.

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CDISC Standards Need Volunteers Like You!

CDISC relies on volunteers to develop and improve data standards products. The best way to get involved is to download and use CDISC standards, and to participate as a reviewer of new standards posted for comment on our website.

The following CDISC teams are also currently looking for new participants:

• XML Afficionados
• Protocol Representation
• Terminology

Follow the link to know more about how to volunteer! Further questions, please email us here.

Also stay tuned for an upcoming webinar where we will describe how to get more actively involved in CFAST Therapeutic Area Data Standards project teams. Details on our webinars can be found here. 

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CDISC Global Events and Education Opportunities 

CDISC Interchanges

• CDISC International Interchange in North Bethesda, MD, 4 - 8 November 2013. We are now accepting abstracts on case studies that include metrics on utilizing the CDISC standards. Deadline for abstract submission is 16 July 2013. Click here to submit your abstract online.
  
• Mark your calendars for the next CDISC European Interchange on 7-11 April 2014 in Paris, France. Information will be posted soon on the CDISC website.
  

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CDISC Standards Latest Updates Webinars

Join us for our monthly webinars to hear the latest updates and achievements on the CDISC standards. Click here to view the scheduled webinars in 2013.

Our next webinar is scheduled on 6 June 2013. Click here to see more details on the topics and registration information.

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CDISC Education Courses Opportunities

CDISC is offering six public education events between now and the International Interchange in Bethesda, MD November 2013. The next three education offerings are listed below and limited seats are still available. Future education events can be found on our web site. As always, you can still request private training for your organization. For more information on CDISC private training, please visit the following webpage.

21-24 May - CDISC Public Training, St. Louis, MO Hosted by Biomedical Systems

Courses Offered:

• SDTM Theory and Application (21-22 May 2013); 2-day Course
• CDASH Implementation (23 May 2013)
• ADaM Implementation (24 May 2013)

Online registration has closed but you can still attend this education event by filling out offline registration form to attend this event.

Did you know: CDISC only authorizes the most qualified instructors to teach our CDISC Education courses. Our instructors come from various backgrounds and have taught CDISC Education courses worldwide.

4-7 June - CDISC Public Training, Audubon, PA Hosted by BioClinica

Courses Offered:

• SDTM Theory and Application (4-5 June 2013); 2-day Course
• CDASH Implementation (6 June 2013)
• ADaM Implementation (7 June 2013)

Online registration has closed but you can still attend this education event by filling out offline registration form to attend this event.

Did you know: This is the third consecutive year a CDISC Public Course offering is held at BioClinica in Audubon, PA. There is a strong demand for CDISC standards in the area and we expect the demand to grow in the coming years.

17-July - CDISC Public Training, Cambridge, MA Hosted by Sanofi (Genzyme)

Courses Offered:

• ADaM Implementation (17 July 2013)

Online Registration ends 17 June 2013. Click here to register. You can also register using the offline registration form by clicking here.

Did you know: Unsure if you should attend this event? Feel free to contact us at training@cdisc.org or feel free to stop by the CDISC booth at the DIA Annual Event in Boston, MA next month from 24-26 June.

9-12 September - CDISC Public Training, Brussels, Belgium Hosted by Business and Decision Life Sciences

Courses Offered:

• SDTM Theory and Application (9-10 Sep 2013); 2-day Course
• CDASH Implementation (11 Sep 2013)
• ADaM Implementation (12 Sep 2013)

Online Registration ends 9 August 2013. Click here to register. You can also register using the offline registration form by clicking here.

Did you know: This is the third consecutive year a CDISC Public Course offering is held at Business & Decision Life Sciences in Brussels, Belgium. Two authorized CDISC instructors whom work for Business & Decision will conduct the SDTM and CDASH courses. Register now to reserve your slot!

CDISC Upcoming Standards Webinar and Other News & Updates:

• Next CDISC Standards and Updates Webinar scheduled for 6 June. Click here to register.
• SDTM Basics Online Training to be rolled out soon. Stay tuned for more info!
• Program and courses offered at International Interchange to come out in the summer.

For more information on upcoming CDISC Education events, please visit the CDISC Education webpage.

What our attendees are saying about CDISC courses:

"The course effectively explained the structure of ADAM data in a way that increased the probability we can implement it better. It also demonstrated the importance of metadata for data and results."

-ADaM 'In-House' Private Course on 14 Jan 2013

"It was a very well organized 2-day course. It was full of information with great examples, and promotion of discussion (Q&A). The instructor was well versed in SDTM & CDASH, so any variation of question was understood by the instructor, and answered thoroughly. The USB notes were fantastic and kept attention focused on the instructor and her instructions."

-SDTM Public Course in South San Francisco, CA on 6 Mar 2013

"Very good speaker. She is highly accomplished and clearly an energetic driver behind CDISC. Don't often like to use the word in connections like this, but she is "passionate" about CDISC, it shows and it rubs off on the audience. Very open session, Great answers to questions, time flew by."

-CDASH Public Course in Morrisville, NC on 14 Feb 2013
 

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The Official CDISC Primer is available for a lower price  

Benefit from the discounted price and buy the CDISC book now! Current Price is $10.

The CDISC Primer (Introducing the CDISC Standards / New Efficiencies for Medical Research) offers a detailed synopsis around everything you need to know to get started with the CDISC standards! Order yours today!

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Stay connected with the CDISC community through the CDISC social media. Join CDISC Facebook and LinkedIn and follow us on Twitter and YouTube! And follow our Blogs and most recent News through our website!

Further questions are welcome through the following email.

CDISC Communications and Public Relations

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.

CDISC standards are freely available via the CDISC website. To learn more about the PKD Therapeutic Area User Guide and to download the associated standards package, please visit the CDISC website: http://www.cdisc.org/therapeutic.

“This release marks another major milestone in the development of a set of global, platform-independent therapeutic area data standards. The way we were able to work with academic clinicians from Emory University, the Mayo Clinic, Tufts University and the University of Colorado-Denver to develop and reach consensus on PKD data elements was ground breaking for us.

Audio presentation available here.

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.

The 2013 Europe Interchange Keynote will be delivered by Dr. Michel Goldman, head of the Innovative Medicines Initiative (IMI). Frank Petavy of the European Medicines Agency (EMA) will give a presentation on the Clinical Trial Transparency Initiative, and Dr. Charles Cooper of the U.S. Food and Drug Administration (FDA) will present on Data Standards in the FDA – Challenges and Processes. Additional Interchange speakers will represent TransCelerate Biopharma and CDISC members and standards adopters. “We are extremely pleased that experts will be presenting on behalf of FDA, EMA and IMI during this 10th CDISC European Interchange, which will be held in Bad Nauheim (near Frankfurt), where Elvis Presley spent two years of his life,” said Peter van Reusel, who chairs the E3C. “We can look forward to a very special evening event, for which our European Interchanges have become renowned.”

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.

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.

“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.”

This new resource, the Parkinson’s disease CDISC Therapeutic Area Data Standard, provides a defined and consistent way to store, and submit clinical trial data for PD. The new standard will help researchers combine and evaluate data from multiple studies, streamline the efficiencies of new clinical trials, and aid the evaluation of new drugs and treatments for PD.

Carolyn Compton, M.D. and Ph.D., is the current President and CEO of the Critical Path Institute (C-Path), which is partnered with CDISC through the Coalition For Accelerating Standards and Therapies (CFAST) and other initiatives such as the Coalition Against Major Diseases (CAMD) and the Critical Path to TB Drug Regimens (CPTR) through which the CDISC Alzheimer’s Disease and Tuberculosis standards were developed, respectively. Dr. Compton’s professional history is impressive, with 15 years spent as the Director of Gastrointestinal Pathology at the Massachusetts General Hospital, as a Professor of Pathology at Harvard Medical School and the Chair of Pathology and Pathologist-in-Chief at McGill University Health Center. Before taking on her current role at C-Path, Dr. Compton was Director of the Office of Biorepositories and Biospecimen Research and the Executive Director of the Cancer Human Biobank Project at the National Cancer Institute, where she was critical in implementing a number of key, groundbreaking research informatics solutions that were based on data standards.

“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.

Austin, TX – 5 December 2012 – The Clinical Data Interchange Standards Consortium (CDISC) is proud to announce the launch of the inaugural CDISC Asia-Pacific Interchange to be held 18-22 February 2013 in Singapore. Singapore was chosen for its central location in this region, the epicenter of some of the most booming economies in the world.

“We are excited to offer this Interchange in Singapore, an event which essentially brings CDISC to the doorstep of our many loyal members and supporters throughout the Asia-Pacific region. This Interchange will offer companies in Asia-Pacific the rare opportunity to collaborate with and gain information about best practices in clinical data standards implementation from their peers in the region,” said Paula Brown Stafford, President of Clinical Development at Quintiles and CDISC Board Chair.

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.

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!

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.

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.

Formal Launch of CFAST - collaboration between C-Path and CDISC

Austin, TX - 12 September 2012 - The Clinical Data Interchange Standards Consortium (CDISC) and Critical Path Institute (C-Path) announce the launch of the Coalition For Accelerating Standards and Therapies (CFAST), a follow-up to the partnership agreement signed earlier this year. The official launch of CFAST will take place at the CDISC 2012 International Interchange in Baltimore, Maryland (24-26 October 2012).

CFAST is an initiative to accelerate clinical research and medical product development by facilitating the creation and maintenance of data standards, tools, and methods for conducting research in therapeutic areas important to public health. To date, CDISC has either released draft or provisional standards packages covering five different disease areas: Parkinson’s, Alzheimer’s, Tuberculosis, Virology and Pain. Upcoming releases will include therapeutic area standards packages for Polycystic Kidney Disease, Cardiovascular Disease and Schizophrenia.

This new tool—a standardized way to report research data—is critical for advancing new TB drug regimens. For the first time, researchers are able to combine and evaluate data from multiple studies using a common approach. This will help accelerate the development of new TB drugs by enhancing the design of clinical trials and the evaluation of new drugs. The TB data standards will also assist the regulatory review process for new drug development tools, such as clinical trial simulation models and methods to evaluate treatment endpoints.

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.

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.

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.

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.”

This challenge will provide FDA, HHS/ONC and CDISC a means to assess the remaining barriers as well as the opportunities to streamline regulated clinical 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 clinical research dataset that is needed for any regulated clinical research study.”

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.

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.

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:

Questions and comments are welcome here!

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!

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!  

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!  

Version 1.0 of an Alzheimer’s data standard, used to develop the C-Path Coalition Against Major Diseases’ (CAMD) groundbreaking Alzheimer’s Disease data repository, was developed through the CDISC process and posted to the CDISC website in October 2011. Since this first major milestone, CDISC and C-Path and such partners as the Bill and Melinda Gates Foundation, the Michael J. Fox Foundation, the PKD Foundation, Tufts University, Rochester University, the National Institutes of Health (NIH) and others have continued to make advancements in a number of therapeutic areas. Tuberculosis, Pain, Parkinson’s Disease, Polycystic Kidney Disease, Virology, Oncology, and Cardiovascular Disease are therapeutic areas for which standards are currently in development.

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.

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.

Key successes CDISC has had over the past 15 years are displayed graphically in a two-page timeline detailing major achievements since the organization’s founding in 1997. The report includes the mission and vision of CDISC, milestones for year 2011, and information about CDISC-certified education. Trends in CDISC membership and current leadership information are also detailed. Fascinating insight is given in the Annual Report to the rapid growth and productivity of CDISC since its beginnings as a strictly volunteer organization.

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. 

“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.

Read an example.

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

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.

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."

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?

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)

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.

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).

"Initiating the study design and protocol process in a structured manner while incorporating CDISC standards use drives efficiency throughout the entire study life,” said David Gemzik, Chair of the Protocol Representation Group. “The Toolkit creates a foundation upon which a standards-driven approach can be implemented."

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.

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.

PK Tandon, Clinical Science Officer, Clinical Development, and an Executive Sponsor of both the GetSMART and RegistryNXT! Programs at Genzyme stated “We are very pleased to have received these awards and even more pleased to see the beginnings of adoption in parts of the broader Sanofi organization. This was truly a team effort with input from various stakeholders. We live in an increasingly complex clinical data environment. CDISC standards have helped to streamline our information handling processes, facilitated exchange with external parties, and improved our ability to create integrated datasets to speed answers to regulatory and scientific questions.”

“We are delighted to congratulate the Genzyme teams for their extraordinary work in earning these awards,” stated Rebecca Kush, President and CEO, CDISC. “Both GetSMART and RegistryNXT! are stellar examples of how to gain the most value from CDISC standards---building them into the process from the start and beginning with the end in mind. It is very gratifying to see how CDISC standards can be applied so effectively to provide real business value within the clinical research industry as well as value for patients.”

The meeting will endeavor to advance work initiated at previous annual FDA Computational Science meetings by bringing together the FDA, industry and academia to provide updates on ongoing current initiatives within the FDA and to establish collaborative working groups to address current challenges related to the access and review of data to support product development. These collaborative working groups will pursue possible solutions and practical implementations with the goal of helping the broader community align and share experiences to advance computational science, while exploring the advantages of using CDISC standards more extensively throughout the research process.

The goal of the CDISC Device Team, comprised of representatives from AdvaMed member device companies, CDISC experts, FDA-CDRH (Center for Devices and Radiological Health), and FDA-CBER (Center for Biologics Evaluation and Research), has been to identify the basic data collection fields, the submission variables, and associated metadata and mappings to support the majority of device studies and modalities, i.e. diagnostic devices, implantable devices and imaging devices. “These seven new proposed SDTM Device domains are a major milestone for the CDISC Devices Team,” quoted Carey Smoak of Roche, charter member and current Co-Leader of the CDISC Devices Team. “We encourage review from the clinical research community in the effort to ensure that this draft standard effectively meets the needs of all audiences.”

With CDISC’s expanded efforts in Europe, there is great excitement and anticipation surrounding the upcoming 2012 CDISC European Interchange, set for 16-20 April in Stockholm, Sweden. The Plenary session will begin with opening remarks by the CDISC Board Chair, Paula Brown Stafford and Chair-elect Pierre-Yves Lastic, who has also led the E3C for the past two years. Plenary speakers will be an expert line-up: Professor Marie Lindquist of the Uppsala Monitoring center, who is working with CDISC and the World Health Organization (WHO) on an important project; Dr. Bernard de Bono of the European Bioinformatics Institute, who will speak about some of the IMI initiatives in which CDISC is involved; Ms. Lisa Spellman, Secretariat of the International Standards Organisation’s (ISO) Technical Committee on healthcare standards (TC215); representatives from the U.S. Food and Drug Administration (FDA); CDISC President, Dr. Rebecca Kush and new CDISC Chief Technology Officer, Wayne Kubick. The EU Interchange week will also include the Annual Meeting of the CDISC Board of Directors and a CDISC Advisory Board (CAB) meeting. “We are extremely pleased to have such a qualified, diverse and relevant set of Plenary session speakers, and the presentations to follow have been carefully selected from excellent abstracts on real-world implementation experiences with CDISC standards globally,” commented Dr. Lastic of Sanofi. “We hope to attract those who have attended before in addition to a new set of attendees in new areas where CDISC standards are now developing significance, such as devices, biotechnology and therapeutic areas. With the CDISC entity in Europe, the opportunities for CDISC continue to expand exponentially here.”

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!

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.

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.

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.

Following the charter of the Board of Directors, we will also appoint new members of the Executive Committee of the Board. Dr. Frank Rockhold will become Past-Chair while Paula Brown Stafford takes the helm as Chair of the CDISC Board of Directors. “I look forward to utilizing my clinical research experience to assist the CDISC team achieve its vision of Informing patient care and safety through higher quality medical research and to meet the strategic goals of the CDISC Board for 2012-2015,” stated Ms. Brown Stafford. The new Chair-Elect will be Dr. Pierre-Yves Lastic. Dr. Edward Helton will complete his term as Past-Chair and his service on the Executive Committee; CDISC is extremely grateful for his many years of Board service to CDISC.

Austin, TX – 20 December 2011 – On Monday, 5 December, CDISC was notified by the U.S. Internal Revenue Service (IRS) that it is approved as a 501(c)(3) organization, recognizing CDISC as a charitable organization retroactive to May 2011. While CDISC has been a 501(c) tax-exempt, non-profit organization since February 2000, this new status offers added benefits to assist CDISC in achieving its mission, vision and goals.

Just one of the benefits of this new status is the ability to receive tax-deductible contributions from individual and corporate donors. This will assist in promoting CDISC’s message to a broader audience, enhancing CDISC’s capacity to locate funds through diverse means. CDISC has always been exempt from paying federal corporate income tax, but will now no longer be required to pay sales tax; this will allow for these funds to be put toward CDISC’s strategic goals, which include the development of global disease-specific research standards to benefit patients around the world. Follow the link.

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.

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.

Brussels – 15 December 2011 – The Innovative Medicines Initiative Joint Undertaking (IMI) and the Clinical Data Interchange Standards Consortium (CDISC) are pleased to announce that they have signed an agreement and initiated activities to enhance the use of information gathered for the purpose of developing safer, more effective innovative medicines for patients. The agreement was spearheaded by Ann Martin, Principal Scientific Manager for Knowledge Management at IMI. “To effectively manage information across a variety of projects requires a common format at the elemental level,” stated Ms. Martin. “Our stakeholders felt strongly that it is good practice to adopt data standards. CDISC already provides such standards enjoying wide adoption in the pharmaceutical industry. The CDISC standards therefore could be considered as a default standard for research conducted through the IMI projects. Moreover, CDISC not only focuses on global clinical research, but also collaborates to harmonise with global healthcare standards bodies such as the International Organization for Standardization (ISO), Health Level Seven International (HL7) and the European Committee for Standardization (CEN) through a Joint Initiative Council (JIC).”

IMI, a joint undertaking between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA), is the world’s largest public-private partnership initiative aiming to speed up the development of better and safer medicines. With its €2 billion research fund, IMI supports collaborative projects through consortia comprising academic experts, small and medium-sized enterprises, patients’ organisations, pharmaceutical companies, and regulators to support innovation in research and development in Europe. The IMI projects range from finding new biomarkers for the development of safer and more effective treatments for patients, to educating researchers and using electronic health records for various research purposes.

CDISC has developed consensus-based data formats that provide a common global ‘language’ and enablers for obtaining, using and sharing information to enhance science and improve research and healthcare. The CDISC suite spans the research process from the study plan (protocol) through data analysis and reporting. CDISC also provides enablers for using electronic health records (EHRs) for research. CDISC has become increasingly involved during the past few years in developing data formats to support specific disease areas such as tuberculosis (working with the TB Alliance, Gates Foundation and Critical Path Institute), Alzheimer’s disease, Parkinson’s disease, pain, oncology and other such therapeutic areas.

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.

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.

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)

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?)