具有混合二元和连续反应的II期临床试验的先前有效样本量

IF 16.4 1区化学 Q1 CHEMISTRY, MULTIDISCIPLINARY

Accounts of Chemical Research Pub Date : 2022-11-07 DOI:10.1111/stan.12283

Meghna Bose, J. Angers, A. Biswas

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引用次数: 0

摘要

在毒性和疗效是治疗反应载体的两个组成部分的II期临床试验中，寻找有效样本量(ESS)的问题被考虑。特别地，假设其中一个分量是二元的，另一个是连续的。研究了不同设置下不同先验分布的二元安全性和持续有效性情况。在各种情况下得到理论表达式。通过仿真研究对这些方法进行了评价和比较。然后，通过使用Covid - 19 II期疫苗试验的一些真实数据来说明所提出的方法。

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Prior effective sample size in phase II clinical trials with mixed binary and continuous responses

The problem of finding Effective Sample Size (ESS) in Phase II clinical trials where toxicity and efficacy are the two components of the treatment response vector is considered. In particular, one of the components is assumed to be binary and the other is assumed to be continuous. The case of binary safety and continuous efficacy is studied for different prior distributions under different set up. Theoretical expressions are obtained in various situations. The methods are evaluated and compared by simulation studies. The proposed method is then illustrated by using some real life data on a phase II vaccine trial for Covid‐19.

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来源期刊

Accounts of Chemical Research 化学-化学综合

CiteScore

31.40

自引率

1.10%

发文量

312

审稿时长

2 months

期刊介绍： Accounts of Chemical Research presents short, concise and critical articles offering easy-to-read overviews of basic research and applications in all areas of chemistry and biochemistry. These short reviews focus on research from the author’s own laboratory and are designed to teach the reader about a research project. In addition, Accounts of Chemical Research publishes commentaries that give an informed opinion on a current research problem. Special Issues online are devoted to a single topic of unusual activity and significance. Accounts of Chemical Research replaces the traditional article abstract with an article "Conspectus." These entries synopsize the research affording the reader a closer look at the content and significance of an article. Through this provision of a more detailed description of the article contents, the Conspectus enhances the article's discoverability by search engines and the exposure for the research.