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Some comments on frequently used multiple endpoint adjustment methods in clinical trials

Some comments on frequently used multiple endpoint adjustment methods in clinical trials Confirmatory clinical trials often classify clinical response variables into primary and secondary endpoints. The presence of two or more primary endpoints in a clinical trial usually means that some adjustments of the observed p‐values for multiplicity of tests may be required for the control of the type I error rate. In this paper, we discuss statistical concerns associated with some commonly used multiple endpoint adjustment procedures. We also present limited Monte Carlo simulation results to demonstrate the performance of selected p‐value‐based methods in protecting the type I error rate. © 1997 by John Wiley & Sons, Ltd. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Statistics in Medicine Wiley

Some comments on frequently used multiple endpoint adjustment methods in clinical trials

Statistics in Medicine , Volume 16 (22) – Nov 30, 1997

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Publisher
Wiley
Copyright
Copyright © 1997 John Wiley & Sons, Ltd.
ISSN
0277-6715
eISSN
1097-0258
DOI
10.1002/(SICI)1097-0258(19971130)16:22<2529::AID-SIM692>3.0.CO;2-J
Publisher site
See Article on Publisher Site

Abstract

Confirmatory clinical trials often classify clinical response variables into primary and secondary endpoints. The presence of two or more primary endpoints in a clinical trial usually means that some adjustments of the observed p‐values for multiplicity of tests may be required for the control of the type I error rate. In this paper, we discuss statistical concerns associated with some commonly used multiple endpoint adjustment procedures. We also present limited Monte Carlo simulation results to demonstrate the performance of selected p‐value‐based methods in protecting the type I error rate. © 1997 by John Wiley & Sons, Ltd.

Journal

Statistics in MedicineWiley

Published: Nov 30, 1997

There are no references for this article.