American Statistical Association
New York City
Metropolitan Area Chapter

Memorial Sloan-Kettering Cancer Center
Biostatistics Seminar



Masha Kocherginsky, Ph.D.
Associate Professor
Department of Public Health Sciences
University of Chicago

TRIAL DESIGN AND ENDPOINT SELECTION
IN PHASE II CLINICAL TRIALS

Recently there has been a lot of discussion about what are the appropriate designs and endpoints in Phase II cancer clinical trials. Single arm designs, including the long-term staple, Simon's two-stage design, have become less popular because of concerns about the adequacy of historical controls, bias due to population selection, and recent availability of a new class of molecularly targeted agents which do not necessarily shrink tumors, but rather have different mechanisms leading to clinical benefit. The Clinical Trial Design Task Force of CTEPís Investigational Drug Steering Committee, the Methodology for the Development of Innovative Cancer Therapies (MDICT) task force, and editors of JCO have encouraged greater use of randomization and alternative endpoints for Phase II trial design. Many now agree that randomized Phase II designs are preferable, although they come with a host of problems of their own, the most obvious one being prohibitively large sample size requirements. So, what is a biostatistician to do? In this talk, I will discuss issues surrounding the design and endpoint selection of randomized Phase II cancer trials, and will present feasibly-sized randomized trial designs based on the continuous tumor size change.


Date: Wednesday, November 12, 2014
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)
3rd Floor Conference Room
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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