FDA Works with Partners to Establish Important Therapeutic Area Data Standards

FDA: October 24, 2012

A new partnership between the FDA, the Clinical Data Interchange Standards Consortium (CDISC), and the Critical Path Institute (C-Path) was officially launched today at the CDISC International Interchange in Baltimore. This partnership, called the Coalition For Accelerating Standards and Therapies or CFAST, will bring together clinical data experts from the FDA, the pharmaceutical industry, and the information technology sector, to develop and maintain data standards tailored to individual diseases and therapeutic areas.

While I was preparing my keynote address for the Interchange, I began thinking of how history provides us lessons for the future, and the Great Baltimore Fire of 1904 is a particular example that stands out in my mind. In this tragedy, thousands of firefighters from surrounding cities and states responded to Baltimore’s call for help, but they were unable to assist in putting out the fire because their hoses and equipment were not compatible with the Baltimore hydrant connections.  This terrible event made the need for standardized fire-fighting equipment and connections devastatingly clear. Read more