临床试验中访视时间与入组速度对瓮模型组间分配比例的影响

Effects of study duration and interview duration on allocation proportions randomized by urn model in clinical trial

瓮模型是适应性设计的一种最基本最常用的随机化方法。本文模拟研究了研究周期从半年至两年,访视时间从7 d到56 d的各种组合下的临床试验使用瓮模型进行反应变量-适应性随机化的组间分配比例,结果表明访视时间、研究周期对于使用瓮模型进行反应变量-适应性随机化存在一定的影响,或者使得结果呈现某种趋势,但是其影响的绝对值之间差异并不是很大。通过以上的分析验证,希望为随机化胜者优先原则在新药临床研究中的实际应用提供参考。

Urn model is a most commonly used randomization method of adaptive design.In this article,given the study time were from 6 to 12 months and the interview time were from 7 to 56 days,urn model was used to calculate the allocation proportions between the two treatments groups through simulation experiments.The outcomes indicated that the effects of study duration and interview duration on randomization results exactly exist,but they were not as serious as we assumed for the differences of effective modulus were not significant.We hope this study can provide some references for the application of RPW rule in practical clinical trials.