CDISC Responds to TransCelerate Questions


Applied Clinical Trials

Thanks for your interesting article “What We Can Anticipate from TransCelerate,” We greatly appreciate Mr. Ivsin’s kind remarks about CDISC being “a respected, popular and useful initiative” in his discussion of Project 4.  But I’d like to issue a clarification to his comments about the development of clinical data standards.

The article begins by wondering what happened to CDISC, and asks how TransCelerate could possibly improve what we do.

Rest assured; we’re still here.  In fact, TransCelerate has been working closely with CDISC for several months to see how they can help us move more quickly in the development of therapeutic area data standards.  Specifically, they are working to provide CDISC with knowledgeable staff to help us plan for and develop data standards for more than 55 therapeutic areas over the next five years.  This work is being performed under a new partnership, the Coalition for the Advancement of Standards and Therapies (CFAST), which was established by CDISC and the Critical Path Institute with involvement from FDA, TransCelerate, and the CDISC global community of volunteers and member companies.  The CFAST initiative will have a formal kickoff at the CDISC 2012 International Interchange, in Baltimore later this month.

The CFAST charter requires that any clinical data standards produced under this partnership will be produced under the CDISC standards development process, and will be published openly as CDISC standards.  But the important thing to realize is that TransCelerate intends to help CDISC achieve its mission to develop therapeutic area data standards more rapidly by giving us greater access to skilled volunteers to contribute to standards development projects.   TransCelerate is certainly not trying to “supplant” CDISC as the article speculates; rather, they are seeking to enable faster progress.  We at CDISC greatly appreciate the contributions from TransCelerate and all of our supporters and are looking forward to making great progress on this initiative in the coming years with their assistance.

Wayne Kubick
Chief Technology Officer

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