FDA works with partners to establish important therapeutic area data standards

November 5, 2012 by MassDevice

Janet Woodcock

By:  Janet Woodcock, M.D.

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.

Sign up to get our free newsletters delivered right to your inbox.

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.

As part of the changing tide of drug regulation, we are seeing ever-increasing streams of data coming into the agency. However, much like standardized fire-fighting equipment, we need to develop standardized definitions for individual diseases and the therapeutic approaches to treat them to be able to tap into this data stream.

Comments

Built on an AdaptiveTheme using Drupal by Michael Knapp  mknapp