A statistical method for protocol modifications with heterogeneous population variances
學年 112
學期 2
出版（發表）日期 2024-06-26
作品名稱 A statistical method for protocol modifications with heterogeneous population variances
作品名稱（其他語言）
著者 Chiang, Chieh
單位
出版者
著錄名稱、卷期、頁數 Statistics in Biopharmaceutical Research
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.
關鍵字 heterogeneous variabilities;protocol amendment;sample size adjustment
語言 en_US
ISSN
期刊性質 國外
收錄於 SCI
產學合作
通訊作者
審稿制度 是
國別 USA
公開徵稿
出版型式 ,電子版
相關連結

機構典藏連結 ( http://tkuir.lib.tku.edu.tw:8080/dspace/handle/987654321/125842 )