Abstract:
:Some covariate-adaptive randomization methods have been used in clinical trials for a long time, but little theoretical work has been done about testing hypotheses under covariate-adaptive randomization until Shao et al. (2010) who provided a theory with detailed discussion for responses under linear models. In this article, we establish some asymptotic results for covariate-adaptive biased coin randomization under generalized linear models with possibly unknown link functions. We show that the simple t-test without using any covariate is conservative under covariate-adaptive biased coin randomization in terms of its Type I error rate, and that a valid test using the bootstrap can be constructed. This bootstrap test, utilizing covariates in the randomization scheme, is shown to be asymptotically as efficient as Wald's test correctly using covariates in the analysis. Thus, the efficiency loss due to not using covariates in the analysis can be recovered by utilizing covariates in covariate-adaptive biased coin randomization. Our theory is illustrated with two most popular types of discrete outcomes, binary responses and event counts under the Poisson model, and exponentially distributed continuous responses. We also show that an alternative simple test without using any covariate under the Poisson model has an inflated Type I error rate under simple randomization, but is valid under covariate-adaptive biased coin randomization. Effects on the validity of tests due to model misspecification is also discussed. Simulation studies about the Type I errors and powers of several tests are presented for both discrete and continuous responses.
journal_name
Biometricsjournal_title
Biometricsauthors
Shao J,Yu Xdoi
10.1111/biom.12062subject
Has Abstractpub_date
2013-12-01 00:00:00pages
960-9issue
4eissn
0006-341Xissn
1541-0420journal_volume
69pub_type
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