PERMUTATION TEST FOLLOWING COVARIATE-ADAPTIVE RANDOMIZATION IN RANDOMIZED CONTROLLED TRIALS

摘要

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 covanate-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.