Guidance Gives Provisional Endpoints, IBS Trial Designs 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 for public use. Once qualified IBS PRO measures are developed, they will replace the provisional endpoints in the guidance, the agency said.
Clinical Trials Advisor