Handling Covariates in the Design of Clinical Trials

Details Handling Covariates in the Design of Clinical Trials Handling Covariates in the Design of Clinical Trials

2011-02-18

arxiv.org/abs/1102.3773v1

Statistical Science 2008, Vol. 23, No. 3, 404-419

Statistics

Methodology

Published in at http://dx.doi.org/10.1214/08-STS269 the Statistical Science (http://www.imstat.org/sts/) by the Institute of M

Scientific paper

10.1214/08-STS269

There has been a split in the statistics community about the need for taking covariates into account in the design phase of a clinical trial. There are many advocates of using stratification and covariate-adaptive randomization to promote balance on certain known covariates. However, balance does not always promote efficiency or ensure more patients are assigned to the better treatment. We describe these procedures, including model-based procedures, for incorporating covariates into the design of clinical trials, and give examples where balance, efficiency and ethical considerations may be in conflict. We advocate a new class of procedures, covariate-adjusted response-adaptive (CARA) randomization procedures that attempt to optimize both efficiency and ethical considerations, while maintaining randomization. We review all these procedures, present a few new simulation studies, and conclude with our philosophy.

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