CDISC Blog

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

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

Dr. Kush then spoke of the value of standards (in particular metadata), providing an example of what happened in 1999 when two scientists used different measurement units--- the metric system and the imperial system; this ‘miscommunication’ of data resulted in the costly loss of the “Mars Climate Orbiter” and eventually resulted in an ISO standard for the Metric Unit. She also appreciated the fact that World Standards Day declared by ISO occurred on 14 October 2011, conveniently happened during the CDISC International Interchange last year in Baltimore, MD. This example of the importance of metadata was used in the ISO publication in October 2011 and is a popular example used over the years by CDISC for educational purposes.

Dr. Kush highlighted two CDISC surveys, which were conducted during the CDISC European Interchange 2011 and the CDISC International Interchange 2010. An outstanding value of CDISC (according to our stakeholders and participants in these surveys) is the availability of Open and Free Standards, allowing any organization to benefit from the work of CDISC…. and to contribute to the CDISC mission and vision for the betterment and safety of patients. Development of additional CDISC Standards (e.g. for specific therapeutic areas) was the area where the survey respondents felt that CDISC could best provide additional value for them. The full set of results of these surveys can be found in the CDISC eJournal via the CDISC website.

On the theme of collaborations, Dr. Kush briefed the audience on the CDISC global picture. CDISC has opened the CDISC Europe Foundation, a non-profit entity based in Brussels; through this entity, CDISC can now participate directly as a member in IMI consortia and is currently participating in several of the IMI projects. In 2011, CDISC was also U.S. IRS approved as 501(c) (3), thus it is now considered a charitable organization that can accept tax-deductible contributions, which should be beneficial in the development of therapeutic area standards. Other important collaborations were emphasized as well. CDISC is currently the leader of the Joint Initiative Council (JIC) for global harmonization of standards (and there was an excellent plenary presentation by the secretariat of ISO TC 215 for healthcare standards). CDISC is also partnering with the Critical Path Institute to develop additional standards (and there was an opening presentation on this work by Bron Kisler). The Translational Research Informatics Institute (TRI) in Japan have translated CDISC standards into Japanese and a C3C group in China (CSTAR) have been validating translations of CDISC standards into Chinese by Absolute Data Systems. This is not an exhaustive list, rather examples of the global reach of CDISC in building strength through collaboration.

Another very important collaboration has recently resulted in a significant step in the progress of making CDISC standards more useful through a partnership with Medidata. This was announced on 18 April in a press release on the first iteration of a Protocol Representation “Toolkit” for clinical research. The toolkit is being developed by Medidata, a CDISC Platinum member organization, with purpose of making it easier for authors of the research plan or protocol to reap the benefits of the Protocol Representation Model (PRM). This has been a long-term need for the PRM, which was released as a UML model that many protocol authors could not readily implement. The press release can be accessed here.

With an emphasis on Communication, Dr. Kush announced the publication of the first CDISC Annual Report 2011 that was reviewed and approved the Board of Directors during their meeting this week. Please watch for this to be posted in the next couple of weeks and share it within your organizations!

In another effort to improve CDISC Communication, the CDISC website has also been updated to be more user-friendly, making it easier to access and understand the relationships among the CDISC standards and innovations of CDISC. CDISC has also improved its social media to encourage more involvement from the global community – look for us on Facebook now, in addition to Linked In and Twitter. CDISC will continue to issue new articles for the CDISC 2012 eJournal, which includes a series of journal articles written by CDISC experts in 2011. The CDISC eJournal is available on the CDISC website under Resources: http://www.cdisc.org/content3061. If you would like to contribute an article, please do not hesitate to contact Diana Harakeh (dharakeh@cdisc.org), CDISC, Manager of Communications. Another addition to our CDISC Communications team is Andrea Vadakin, Manager of Public Relations. Watch for the blogs on the EU Interchange written by these two invaluable CDISC staff members, who were introduced at the Interchange, and let them know if you want to contribute to the CDISC Success Stories that are now featured in our monthly eNewsletters. Your contributions to the CDISC mission and vision is help keep CDISC successful. Please contact the CDISC communication team at communication@cdisc.org.

Please remember, from the closing slide Dr. Kush showed: “Contribute to Open Free Global Standards to Improve Patient Care”’.

By Diana Harakeh

CDISC, Manager of Communications