Abstract:
:In randomized controlled trials, patients are recruited and randomly allocated to treatments. Patients are never randomly sampled from large population of patients on treatments under study. Therefore, it is important to consider the design and statistical analysis based on the randomization model. In this article, we show theoretically that a permutation test based on the difference in means is identical to analysis of covariance if marginal covariate balance is completely attained. Our theoretical results and Monte Carlo simulation study suggest that the permutation test following Pocock-Simon's covariate-adaptive randomization can be a useful alternative to traditional population-based tests in a confirmatory randomized controlled trial with important prognostic factors. The proposed procedure is illustrated with modified data from the randomized placebo-controlled trial of pirfenidone.
journal_name
J Biopharm Statjournal_title
Journal of biopharmaceutical statisticsauthors
Hasegawa T,Tango Tdoi
10.1080/10543400802527908subject
Has Abstractpub_date
2009-01-01 00:00:00pages
106-19issue
1eissn
1054-3406issn
1520-5711pii
907422332journal_volume
19pub_type
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