FDA Offers Provisional Trial Designs for IBS Studies in Lieu of PRO Tools

The FDA has outlined provisional trial designs, study endpoints and efficacy analyses that can be used for testing and assessing new irritable bowel syndrome (IBS) drugs until a well-defined and reliable patient-reported outcome (PRO) tool — the ideal efficacy assessment instrument — can be developed. The agency is participating in the PRO Consortium, a collaborative group formed by the Critical Path Institute that is developing reliable PRO instruments that will be publicly available.
Washington Drug Letter