CDISC, C-Path, FDA, TransCelerate and the Global CDISC Community Launch Initiative to Accelerate Therapies Through Standards

The CDISC International Interchange in Baltimore, Maryland, held October 2012, marked the formal launch of the Coalition for Accelerating Standards and Therapies (CFAST). At the Interchange meeting, FDA representatives announced that recent statutes mean that FDA will be working with SDOs (i.e. CDISC) to develop the terminology and remaining standards to support specific therapeutic areas and that FDA will begin requiring standardized electronic submissions for evaluation of new therapies/products by 2017. In her keynote presentation at the CDISC Interchange, Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research at FDA, stated “Through CFAST, we seek 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.”

CFAST, announced September 10, is being realized through a partnership between CDISC and the Critical Path Institute (C-Path). The CFAST Charter states that any clinical data standards produced under this partnership will be created under the CDISC standards development process, and those standards will then be published openly on the CDISC website as global CDISC standards. One key objective is to ensure that the CDISC process is robust and consensus-based, yet as rapid as possible. The recently formed TransCelerate BioPharma, Inc. has joined the CFAST partnership to assist CDISC by providing greater access to resources from the pharmaceutical industry that will contribute to standards development projects. “Our goal at TransCelerate with the Therapeutic Area (TA) Data Standards Project is to contribute our efforts and investments to assist and partner with CDISC, C-Path and FDA to complete CFAST TA data standards projects more rapidly and to allow CDISC to roll out new TA data standards every few months as particular disease areas are completed,” said Dr. Garry Neil, CEO of TransCelerate.

“Patients don’t know why standards are important, if they did they would be lobbying Congress to provide more funding for standards development” said Sue Dubman of Sanofi (also on the CDISC Board of Directors and a Parkinson’s patient). “Similar to the FDA reviewer working with a submission, as much as 50% of a researcher’s time in therapeutic product development can be spent on data management (entering and re-entering, copying, pasting, classifying, coding, editing, converting, verifying and reconciling data). Implementing CDISC standards end to end, across the clinical data lifecycle, starting with the CDISC Protocol Representation Model, could automate many time-consuming and labor intensive processes. Every minute that a researcher spends time on managing data instead of analyzing data is a minute lost to product development. From a patient’s point of view that is unacceptable. Time is every patient’s most precious commodity. Patients can’t wait 15-20 years for new treatments to come to market. While standards are not a panacea, they are a necessary component to streamline and shorten the development process. ”