A statistical method for protocol modifications with heterogeneous population variances

淡江大學機構典藏 > 商管學院 > 國際企業學系暨研究所 > 期刊論文 > Item 987654321/125842

jsp.display-item.identifier=請使用永久網址來引用或連結此文件: https://tkuir.lib.tku.edu.tw/dspace/handle/987654321/125842

题名:	A statistical method for protocol modifications with heterogeneous population variances
作者:	Chiang, Chieh
关键词:	heterogeneous variabilities;protocol amendment;sample size adjustment
日期:	2024-06-26
上传时间:	2024-08-05 12:05:15 (UTC+8)
摘要:	During the course of a clinical trial, the procedure may need to be modified based on medical or practical results. For example, in trials with low recruitment rates, the data monitoring committee often changes the inclusion/exclusion criteria, the number of sites, the endpoint, or the protocol itself. When such changes occur, protocol amendments are needed. However, the actual patient population after protocol amendments may be slightly different from the target population. In this study, we focus on the scenario in which the populations have heterogeneous variances across the modifications of trial procedures due to protocol amendments. A statistical method based on the Satterthwaite approximation with corresponding sample size adjustments is developed to evaluate the treatment effect. Our simulation demonstrates that the proposed method controls the type I error rate and provides sufficient power.
關聯:	Statistics in Biopharmaceutical Research
DOI:	10.1080/19466315.2024.2369267
显示于类别:	[國際企業學系暨研究所] 期刊論文

文件中的档案:

档案	描述	大小	格式	浏览次数
index.html		0Kb	HTML	44	检视/开启

在機構典藏中所有的数据项都受到原著作权保护.

TAIR相关文章