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 th...

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Bibliographic Details
Published in:Statistics in medicine 1997-11, Vol.16 (22), p.2529-2542
Main Authors: Sankoh, A. J., Huque, M. F., Dubey, S. D.
Format: Article
Language:English
Subjects:
Algorithms
Clinical Trials as Topic - methods
Computer Simulation
Data Interpretation, Statistical
Humans
Monte Carlo Method
Statistics as Topic - methods
Online Access:Get full text
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Summary: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.
ISSN:0277-6715
1097-0258
DOI:10.1002/(SICI)1097-0258(19971130)16:22<2529::AID-SIM692>3.0.CO;2-J