CDISC Implementation Stories and Using CDISC Standards from the Start of Clinical Studies – Two Panel Sessions at the 2014 CDISC International Interchange


Sessions 5 and 7 of the CDISC International Interchange were distinct from other sessions at the conference, and even from sessions done in the past, in that they hosted a large number of “mini presentations” – short, 5-10 minute presentations by 7-9 speakers, who were asked to keep their presentations to 1-3 slides only, followed by an extended Q&A session for the audience. To be honest, I was skeptical about this set-up, as I wondered if those who had submitted abstracts would accept such a session proposal. But I was in for a surprise, as requested speakers were enthusiastic about this new challenge, and I am even more pleased to report that the audience was more active and engaged during this type of session than I saw during the more traditional session at our conference.


During Session 5, the speakers were asked to put together 1-2 slides to show how their particular company or organization is currently implementing the CDISC standards—‘Implementation Stories’. The session, chaired by Dave Jordan (TransCelerate) and Rebecca Kush (CDISC), had a total of nine speakers from eight organizations (ARIAD, Boehringer-Ingelheim, Genenetech/Roche, Theorem, Sanofi, Eli Lilly and Japan’s Translational Research Informatics Center), thus representing biopharma, CROs and academia. Following an introduction by Dr. Jordan on aspects of the CDISC Business Case and preliminary standards adoption data from Tufts Center for Drug Development, each of the speaker presentations was succinct and immensely practical. There was a full audience of 250-300 attendees during this session, and it was apparent looking around at the audience that they were very actively engaged in understanding how each of these organizations is implementing CDISC standards in real time, including challenges and successes, resource requirements and methods for addressing issues. The representatives from Japan’s TRI Center presented their use of CDISC standards, beginning with protocols from investigators through the generation of CRFs and EDC set-up to SDTM. They can start up a new protocol in a week. (This is the topic of a CDISC webinar).


Strength through Collaboration


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