JSM 2011 Online Program

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Abstract Details

Activity Number: 569
Type: Contributed
Date/Time: Wednesday, August 3, 2011 : 2:00 PM to 3:50 PM
Sponsor: Biometrics Section
Abstract - #303216
Title: Stratified Randomization with Gender-Balancing in the Sure-PD Trial
Author(s): Eric A. Macklin*+ and Michael A. Schwarzschild and Rebecca A. Betensky
Companies: Massachusetts General Hospital and Massachusetts General Hospital and Harvard School of Public Health
Address: 50 Staniford St, Suite 560, Boston, MA, 02114,
Keywords: Randomization ; institutional balancing ; stratification ; clinical trial design ; Parkinson's disease
Abstract:

Randomization designs aim to assign treatments in appropriate proportions while minimizing confounding. In multicenter trials, clinical site can be an important confounder, and randomization is typically stratified by site. When expected enrollment at each site is low, further stratification may not be practical. Study-wide balancing permits balanced treatment allocation marginally for additional potential confounders. We report on four alternative randomization designs for a three-arm multicenter trial in Parkinson's disease: stratification by site, stratification by site and gender, stratification by site with gender balancing, and stratification by gender with site balancing. We compare these designs through simulation with respect to: overall treatment balance, balance by site, balance by gender, drug supply, and power for treatment main effect, interactions, and gender-specific contrasts. We find that stratification by site with gender-balancing is not superior to stratification by both site and gender even with limited enrollment per site. We discuss criteria for choosing among alternative randomization designs for multicenter trials with several potential confounders.


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