FDA publishes non-inferiority draft guidance

FDA released draft guidance on non-inferiority (NI) clinical trials. The guidance focuses on active-controlled NI trials in which use of a placebo would be unethical because a condition is life threatening and an effective treatment exists. FDA also briefly considers two other uses for an NI design: measuring comparative effectiveness and assessing the adequacy of a placebo-controlled trial. In an NI trial for comparative effectiveness, the guidance recommends the use of a placebo in addition to the active control and study drug in order to distinguish between effective and ineffective treatments. ...