American Statistical Association
New York City
Metropolitan Area Chapter

Memorial Sloan-Kettering Cancer Center
Biostatistics Seminar



Mithat Gönen
Memorial Sloan-Kettering Cancer Center

COMBINING HISTORICAL AND RANDOMIZED CONTROLS IN PHASE II TRIALS

This talk will explore ways to combine historical and randomized controls with the goal of justifying unbalanced randomization (smaller controls arms) in Phase II trials. The methodology relies on a power parameter that controls the relative weight of historical controls. This parameter is updated as data accumulate, depending on how similar the randomized and historical controls are. Simulation studies with a binary endpoint indicate that the method strikes a balance between single-arm and 1:1 randomized trials. Adaptive randomization can be used to improve efficiency with binary endpoints but its utility will be limited with time-to-event endpoints which are becoming increasingly popular. SAS and R code are available for trial-based simulations.


Date: Wednesday, November 10, 2010
Time: 4:00 - 5:00 P.M.
Location: Memorial Sloan-Kettering Cancer Center
Department of Epidemiology and Biostatistics
307 East 63rd Street
(between First and Second Avenues)
Room 331
New York, New York
Note: To gain access to the building, please follow the directions by the telephone in the foyer.

RESERVATIONS ARE NOT REQUIRED


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