A statistical method for protocol modifications with heterogeneous population variances

機構典藏 > College of Business and Management > Graduate Institute & Department of International Business > Journal Article > Item 987654321/125842

Please use this identifier to cite or link to this item: https://tkuir.lib.tku.edu.tw/dspace/handle/987654321/125842

Title:	A statistical method for protocol modifications with heterogeneous population variances
Authors:	Chiang, Chieh
Keywords:	heterogeneous variabilities;protocol amendment;sample size adjustment
Date:	2024-06-26
Issue Date:	2024-08-05 12:05:15 (UTC+8)
Abstract:	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.
Relation:	Statistics in Biopharmaceutical Research
DOI:	10.1080/19466315.2024.2369267
Appears in Collections:	[Graduate Institute & Department of International Business] Journal Article

Files in This Item:

File	Description	Size	Format
index.html		0Kb	HTML	44	View/Open