“Non-Inferiority Trials (and Tribulations)” will be presented by Mimi Kim, ScD, Professor and Head, Division of Biostatistics, Department of Epidemiology and Population Health, Albert Einstein College of Medicine.

An increasing number of clinical trials in cancer, HIV/AIDS, and other disease areas are designed as non-inferiority trials, in which the goal is to show that the effect of an experimental therapy is not worse by more than a pre-specified margin than the standard therapy. A particularly difficult issue in these studies is that sources of “noise” that can arise during the trial, such as measurement error, missing data and non-compliance, can obscure treatment differences and lead to anti-conservative results. In this talk, Dr. Kim will provide an overview of ongoing methodological challenges in non-inferiority trials, propose several approaches for addressing the impact of protocol deviations and demonstrate the importance of conducting sensitivity analyses to assess robustness of results.

Join the seminar via Zoom

Participants may also join by calling 929-205-6099, meeting ID 322 043 373. If prompted, enter passcode 167660.