JSM 2005 - Toronto

Abstract #302572

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Legend: = Applied Session, = Theme Session, = Presenter
Activity Number: 463
Type: Invited
Date/Time: Thursday, August 11, 2005 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract - #302572
Title: Adaptive Allocation Methods for Balance of Treatment Assignment
Author(s): Susan Ellenberg*+
Companies: University of Pennsylvania
Address: Center for Clinical Epidemiology and Biostatistics, Philadelphia, PA, 19104,
Keywords: Dynamic Allocation ; Treatment Balance ; Randomization ; Prognostic Factors
Abstract:

Probably the most common method of ensuring balance of treatment assignments within important patient subgroups in clinical trials is stratified randomization. This method involves creating strata for all combinations of factors and creating separate randomization lists for each combination. For example, if one wished to ensure approximately equal numbers of subjects were assigned to each of two treatments within subgroups defined by age (say, 31-40, 41-50, 51-60, 61 and over), gender, and clinical site (assume 5 participating sites), one would require 4x2x5=40 separate randomization lists. Unless the number of individuals to be entered into the study is quite large, such an approach may be no more likely to ensure balance overall and separately by age, gender, and site than simple, unstratified randomization.


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Revised March 2005