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Abstract Details

Activity Number: 198
Type: Roundtables
Date/Time: Monday, July 30, 2012 : 12:30 PM to 1:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #306473
Title: Randomization in Clinical Trials: Design, Conduct, and Analysis
Author(s): Abigail Luo*+
Companies: FDA
Address: 1401 Rockville Pike, Rockville, MD, 20852, United States
Keywords: Randomization ; Stratification ; Minimization

The following topics will be discussed: Randomization ratio, Mechanism of randomization and its potential impact on maintaining study integrity, Whether to stratify, Choice of and number of stratification factors in relation to sample size and other considerations, Incorporation of stratification factors in (primary) statistical analysis. Minimization and adaptive randomization will be discussed as well when time permitted.

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