Simulation study of multi-stage randomized-play-the-winner-rule

Abstract

Abstract: AIM: To present an adaptive randomized method, multi-stage randomized-play-the-winner rule (MSRPW), which facilitates the application of adaptive randomization in clinical trial.METHODS: By using the simulation study, we compared the powers and the mean reduced failures of three different methods, those were traditional equal-probability random allocation, modified randomized-play-the-winner rule and multi-stage randomized-play-the-winner rule.RESULTS: Compared with traditional allocation method, both MRPW and MSRPW could reduced failures in clinical trials, although their powers were decreased slightly. The MRPW reduced the most failures in all scenarios, MSRPW performed as well as MRPW in the scenarios when the difference of effects of test and control groups was not large, or the time interval of adjusting allocation probability was not long, while the traditional allocation performed worst. With the time interval prolonging, MSRPW reduced fewer and fewer failures than MRPW.CONCLUSION: The MSRPW rule proposed in this paper takes both advantages of traditional randomization and MRPW rule into consideration, and more practical than MRPW in clinical trials. MSRPW can be very useful in those scenarios when the difference of effects of the test and control groups is moderate or small, while an appropriate time interval should be chosen carefully when the difference of effects is large.

Key words: Delayed response , Randomized-play-the-winner rule , Urn model , Response-adaptive randomization

CLC Number:

R311

ZHOU Min-lin, WEI Yong-yue, ZHANG Ru-yang, ZHU Jin-jin, YU Hao, CHEN Feng. Simulation study of multi-stage randomized-play-the-winner-rule[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2010, 15(8): 888-893.

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