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首页> 外文期刊>The Journal of Clinical Pharmacology: Official Journal of the American College of Clinical Pharmacology >Evaluation of the cohort size in phase I dose escalation trials based on laboratory data.
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Evaluation of the cohort size in phase I dose escalation trials based on laboratory data.

机译：根据实验室数据，在I期剂量递增试验中评估队列规模。

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摘要

A survey of Phase I dose escalation trials published since 1995 shows that there is great disparity in all aspects of the design of the studies, and the cohort sizes range from 2 to 16 subjects with a great variety in the distribution between active and placebo-treated subjects. This study investigates the impact of the cohort size on Type I error and power in Phase I dose escalation trials based on laboratory data, with the hospitalization-induced increase in hepatic enzyme levels taken into consideration. The power of a Phase I dose escalation trial is very low, and only events with a very high probability of occurrence are detectable with acceptable power. For studies with cohort sizes smaller than 6 active subjects, there is much to gain with the inclusion of 1 extra subject, but for more than 10 subjects, little is gained by increasing the cohort size. With increasing cohort sizes, the probability of spontaneous non-drug-related events also increases, and this background rate needs to be considered when evaluating the trial.
机译：自1995年以来发布的第一阶段剂量递增试验的调查显示，研究设计的各个方面均存在很大差异，队列规模从2到16名受试者，活性药物和安慰剂治疗药物之间的分布差异很大科目。这项研究基于实验室数据，研究了队列规模对I期剂量递增试验中I型错误和功效的影响，并考虑了住院引起的肝酶水平升高。一期剂量递增试验的功效非常低，只有可接受的功效才能检测到发生概率很高的事件。对于队列规模小于6个活跃受试者的研究，增加1个额外的受试者将有很多收获，但是对于10个以上的受试者，通过增加队列规模几乎无济于事。随着队列规模的增加，自发的非药物相关事件的可能性也增加，并且在评估试验时需要考虑该背景发生率。

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