In covariate-adaptive or response-adaptive randomization, the treatment assignment and outcome can be correlated. Under this situation, re-randomization tests are a straightforward and attractive method to provide valid statistical inference. In this paper, we investigate the number of repetitions in the re-randomization tests. This is motivated by the group sequential design in clinical trials, where the nominal significance bound can be very small at an interim analysis. Accordingly, re-randomization tests lead to a very large number of required repetitions, which may be computationally intractable. To reduce the number of repetitions, we propose an adaptive procedure and compare it with multiple approaches under pre-defined criteria. Monte Carlo simulations are conducted to show the performance of different approaches in a limited sample size. We also suggest strategies to reduce total computation time and provide practical guidance in preparing, executing and reporting before and after data are unblinded at an interim analysis, so one can complete the computation within a reasonable time frame.
翻译:在共变适应性或反应适应性随机化中,治疗任务和结果可能是相互关联的。在这种情况下,重新自主测试是一种直接和有吸引力的方法,可以提供有效的统计推断。在本文中,我们调查重新随机化测试中的重复次数。这是由临床试验小组的顺序设计所推动的,临床试验中受约束的名义意义在临时分析中可能很小。因此,重新自主测试导致大量必要的重复,在计算上可能难以处理。为了减少重复,我们建议采用适应性程序,并根据预先确定的标准与多种方法进行比较。蒙特卡洛模拟是用来显示不同方法在有限抽样范围内的绩效的。我们还提出了缩短总计算时间和提供实际指导的战略,以便在临时分析时数据不失明之前和之后进行准备、执行和报告,以便可以在合理的时限内完成计算。</s>