Approximation to the optimal allocation for response adaptive designs.

IF 1.6 3区 医学 Q3 HEALTH CARE SCIENCES & SERVICES Statistical Methods in Medical Research Pub Date : 2024-12-12 DOI:10.1177/09622802241293750
Yanqing Yi, Xikui Wang
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Abstract

We investigate the optimal allocation design for response adaptive clinical trials, under the average reward criterion. The treatment randomization process is formatted as a Markov decision process and the Bayesian method is used to summarize the information on treatment effects. A span-contraction operator is introduced and the average reward generated by the policy identified by the operator is shown to converge to the optimal value. We propose an algorithm to approximate the optimal treatment allocation using the Thompson sampling and the contraction operator. For the scenario of two treatments with binary responses and a sample size of 200 patients, simulation results demonstrate efficient learning features of the proposed method. It allocates a high proportion of patients to the better treatment while retaining a good statistical power and having a small probability for a trial going in the undesired direction. When the difference in success probability to detect is 0.2, the probability for a trial going in the unfavorable direction is < 1.5%, which decreases further to < 0.9% when the difference to detect is 0.3. For normally distribution responses, with a sample size of 100 patients, the proposed method assigns 13% more patients to the better treatment than the traditional complete randomization in detecting an effect size of difference 0.8, with a good statistical power and a < 0.7% probability for the trial to go in the undesired direction.

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响应自适应设计的最优分配逼近。
在平均报酬标准下,研究反应适应性临床试验的最佳分配设计。治疗随机化过程被格式化为马尔可夫决策过程,并使用贝叶斯方法来总结治疗效果的信息。引入了一个跨度收缩算子,并证明了由该算子识别的策略产生的平均奖励收敛于最优值。我们提出了一种算法来近似的最优处理分配使用汤普森抽样和收缩算子。对于具有二元响应的两种治疗方案和200例患者的样本量,仿真结果表明该方法具有有效的学习特性。它将高比例的患者分配给更好的治疗,同时保留了良好的统计能力,并且试验朝着不希望的方向发展的概率很小。当检测到的成功概率之差为0.2时,试验向不利方向进行的概率< 1.5%,当检测到的成功概率之差为0.3时,试验向不利方向进行的概率进一步减小至< 0.9%。对于正态分布的响应,在样本量为100例患者的情况下,在检测到0.8的效应量时,所提出的方法比传统的完全随机化方法多分配13%的患者接受更好的治疗,具有良好的统计能力,试验向不希望的方向发展的概率< 0.7%。
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来源期刊
Statistical Methods in Medical Research
Statistical Methods in Medical Research 医学-数学与计算生物学
CiteScore
4.10
自引率
4.30%
发文量
127
审稿时长
>12 weeks
期刊介绍: Statistical Methods in Medical Research is a peer reviewed scholarly journal and is the leading vehicle for articles in all the main areas of medical statistics and an essential reference for all medical statisticians. This unique journal is devoted solely to statistics and medicine and aims to keep professionals abreast of the many powerful statistical techniques now available to the medical profession. This journal is a member of the Committee on Publication Ethics (COPE)
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