FDA Issues First Draft Guidance on Noninferiority Trials

The FDA has proposed the first draft guidance on noninferiority (NI) clinical trials, which may help increase the availability of comparative information on drugs. NI trials compare a new drug with a proven drug to determine whether the new drug is less effective by an unacceptable margin. The major focus of the guidance is determining the NI margin, which must be estimated based on past performance of the active control drug and by comparing other test conditions to the current environment, according to the draft guidance. Comments are due May 30.
Drug Industry Daily