GAO issues report on non-inferiority trials

The U.S. Government Accountability Office released a review of FDA's use of non-inferiority data in its NDA review process. The report noted that non-inferiority trials raise uncertainties about a compound's true effectiveness because the trials cannot measure effectiveness relative to placebo. The report also said that non-inferiority trial use over time could lead to the adoption of decreasingly effective drugs as active controls and the approval of drugs that are no more effective than placebo. In February, FDA issued draft guidance on non-inferiority trials. ...