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Home » Guidance Gives Provisional Endpoints, IBS Trial Designs in Lieu of PRO Tools
Guidance Gives Provisional Endpoints, IBS Trial Designs in Lieu of PRO Tools
June 20, 2012
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.