A statistical method for protocol modifications with heterogeneous population variances

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題名:	A statistical method for protocol modifications with heterogeneous population variances
作者:	Chiang, Chieh
關鍵詞:	heterogeneous variabilities;protocol amendment;sample size adjustment
日期:	2024-06-26
上傳時間:	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
顯示於類別:	[國際企業學系暨研究所] 期刊論文

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