American Statistical Association
New York City
Metropolitan Area Chapter

Memorial Sloan-Kettering Cancer Center
Biostatistics Seminar



Camelia Sima
Department of Epidemiology & Biostatistics
Memorial Sloan-Kettering Cancer Center

CLINICAL TRIAL DESIGNS FOR BIOMARKER VALIDATION

I will present a review of study designs and statistical issues in biomarker clinical trials. Prognostic and predictive biomarkers are becoming increasingly common in cancer research and clinical applications, with the potential of informing treatment decisions. Their incorporation in the design of clinical trials often requires departures from the standard approaches. This presentation will discuss the merits and limitations of some of the designs that have been recently proposed and implemented, following the structure provided by a summary paper published in Clinical Trials: Mandrekar SJ, Sargent DJ, "Predictive biomarker validation in practice: lessons from real trials," 2010 Oct; 7(5):567-73 (http://ctj.sagepub.com/content/7/5/567.long).


Date: Wednesday, December 1, 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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