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Activity Number: 23 - Increasing Efficiency and Integrity of Randomized Trials: Covariate-Adjusted Randomization and Monitoring Patient Accrual and Selection Bias
Type: Topic Contributed
Date/Time: Sunday, July 30, 2017 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract #324715 View Presentation
Title: Techniques for Matched Randomization in Sequential Enrollment Trials
Author(s): Jonathan J Chipman* and Cole Beck and Robert A Greevy, Jr
Companies: Vanderbilt University and Vanderbilt University and Vanderbilt University
Keywords: Randomization ; Matching ; Study Design ; Clinical Trial
Abstract:

The FDA's Guidance for Industry: E9 Statistical Principles for Clinical Trials presents unrestricted, restricted, and dynamic randomization methods as acceptable. However, unrestricted randomization and stratification using only a few key variables has been shown to be highly inefficient and have a much higher risk of serious imbalance in important covariates than matched randomization, which incorporates all important covariates. Matched randomization can handle cluster randomized trials, multi-arm trials, and be used in trials with enrollment coming all at once or sequentially. Matched randomization has been shown to dramatically improve covariate balance, yielding greater statistical power and more persuasive studies. This talk presents new research on matched randomization with sequential entry including introducing a dynamic matching threshold and Treatment Dependent Matching. Under various simulations settings and with real trial data, we compare the efficiency to estimate a treatment effect using a covariate-adjusted linear model following these extensions versus unrestricted or stratified randomization.


Authors who are presenting talks have a * after their name.

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