FASEB Questions Utility of FDA Pilot

March 09, 2016
In response to a request from the Food and Drug Administration (FDA), the Federation of American Societies for Experimental Biology (FASEB) submitted comments questioning the usefulness of the pilot Clinical Outcome Assessment Compendium (COAC) on March 2. Intended to provide clarity to researchers designing clinical trials or developing new drugs, the COAC combines metrics for evaluating outcomes of drug and other clinical trials for myriad diseases into a single resource. 

Although FASEB appreciates the intent of the COAC and the effort involved in its compilation, the Federation believes it does not provide value above and beyond existing resources. In its comments, FASEB presents three arguments against proceeding with the pilot program: 
  • The information presented in the COAC for any given disease would already be known to researchers well-versed in that area but is too general to be helpful to new investigators
  • The FDA website states that even after consulting the COAC, researchers will still need to contact FDA staff to determine which outcomes and assessments are most appropriate for the trials they’re designing
  • Because clinical trial design and assessments are continually evolving, the time and effort necessary to keep the COAC accurate and current would far outweigh any benefit it provides.
FDA requested input from the stakeholder community on the utility of the pilot COAC and how it could be improved. Comments on the COAC Compendium can be submitted via www.regulations.gov through March 14. 

Categories: Science Policy & Advocacy; Clinical and Translational Research;