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UI Cancer Center Biostatistics and Bioinformatics Monthly Seminar
March 10, 2021 @ 12:00 pm - 1:00 pm CST
“Statistical Consideration of Phase III Clinical Trials”
Zhengjia (Nelson) Chen, PhD
Director of Biostatistics Shared Resource Core UI Cancer Center
Associate Professor, Epidemiology and Biostatistics
Abstract:
In this seminar, I will begin with a brief introduction to Phase III clinical trials and a summary of Phase III designs (randomized clinical trial (RCT) design, factorial design, cross over design, etc.) according to specific purpose of trials. The sample size and power calculation of standard RCT based on time to event endpoint with log-rank test will be introduced. The different group sequential approaches (Haybittle-Peto ad hoc procedure, Pocock group sequential method, O’Brien and Fleming method, and Alpha Spending Function) for multiple interim analyses of ongoing Phase III trial will be compared. Then the popular survival analyses methods (Kaplan Meier method, Log-rank test, and Cox model, etc.) will be also reviewed. Finally, a recent randomized Phase III trial of Remdesivir for the treatment of Covid-19 will be discussed.
Meeting ID: 974 3884 7297
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Meeting ID: 974 3884 7297
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Meeting ID: 974 3884 7297
Passcode: 49636153