Response-adaptive randomization in clinical trials

Abstract

Abstract: AIM: To introduce the response-adaptive randomization, which is one of the randomization strategies in clinical trials.METHODS: The ideas and theories of the play-the-winner rule and randomized-play-the-winner rule, which are two procedures of response-adaptive randomization, are introduced.A simulation study is employed to compare response-adaptive randomization with traditional equal-probability allocation.The advantages and disadvantages of the randomization rules and the issues concerned in implementation of response-adaptive randomization are discussed.RESULTS: The results show that the response-adaptive randomization reduce the number of failures with little decrease in test power than in the case of traditional equal-probability allocation.CONCLUSION: The play-the-winner rule and randomizedplay-the-winner rule deserve the attention of clinicians and statisticians and are suggested in clinical trials after a certain degree of improvement since it is better balanced of the issues between ethics and statistics.

Key words: randomized-play-the-winner rule, urn model, response-adaptive randomization, clinical trial

CLC Number:

R969

LIU Xiao-yan, CHEN Feng, WEI Yong-yue, BAI Jian-ling, YU Hao. Response-adaptive randomization in clinical trials[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2008, 13(6): 684-689.

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