Compound optimal allocation for individual and collective ethics in binary clinical trials

Compound optimal allocation for individual and collective ethics in binary clinical trials
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DOI:
10.1093/biomet/asq055
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发表时间:
2010-12-01
期刊:
影响因子:
2.7
通讯作者:
Giovagnoli, Alessandra
Giovagnoli, Alessandra
中科院分区:
数学2区
文献类型:
--
作者:
Antognini, Alessandro Baldi;Giovagnoli, Alessandra

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近年来,一些作者研究了比较临床试验的反应适应性分配规则,以便在试验的每个阶段支持似乎是最好的治疗。在本文中,我们定义了容许分配,即治疗分配,不能同时改善相对于一个特定的设计标准,反映实验的推理性能,和分配给最佳治疗或治疗的患者比例;我们调查现有的设计从这个角度来看。我们还建议结合信息和伦理考虑,采取适当的加权平均值的两个相应的标准化标准,权重取决于实际的治疗效果。这种复合标准导致局部最优分配,可以通过一些响应自适应随机化规则来实现。本文主要涉及的情况下,两个治疗,但建议的方法是扩展到两个以上。
In recent years, several authors have investigated response-adaptive allocation rules for comparative clinical trials, in order to favour, at each stage of the trial, the treatment that appears to be best. In this paper, we define admissible allocations, namely treatment assignments that cannot be simultaneously improved upon with respect to both a specific design criterion, reflecting the inferential properties of the experiment, and the proportion of patients assigned to the best treatment or treatments; we survey existing designs from this viewpoint. We also suggest combining information and ethical considerations by taking a suitable weighted mean of two corresponding standardized criteria, with weights that depend on the actual treatment effects. This compound criterion leads to a locally optimal allocation that can be targeted by some response-adaptive randomization rule. The paper mainly deals with the case of two treatments, but the suggested methodology is shown to extend to more than two.