American Statistical Association
New York City
Metropolitan Area Chapter

Memorial Sloan Kettering Cancer Center
Department of Epidemiology and Biostatistics
Biostatistics Seminar Series


Mimi Kim, Sc.D.
Professor, Department of Epidemiology & Population Health
Albert Einstein College of Medicine

NON-INFERIORITY TRIALS:
CHALLENGES IN PROVING THERE'S NO NEEDLE IN THE HAYSTACK

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 non-compliance and other protocol deviations, can obscure treatment differences and lead to anti-conservative results. In this talk, I 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.


Date: Wednesday, December 7, 2016
Time: 4:00 - 5:00 P.M.
Location: Memorial Sloan Kettering Cancer Center
Department of Epidemiology and Biostatistics
485 Lexington Avenue
(Between 46th & 47th Streets)
2nd Floor Conference Room B
New York, New York

**Outside visitors please email Tania at celeat@mskcc.org for building access.
You must be on the security list to enter the floor.

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