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Clinical Trials
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Decision rule based multiplicity adjustment strategy

Xun Chen

Clinical Biostatistics, Sanofi-Aventis, Bridgewater, NJ 08807, USAxun.chen{at}sanofi-aventis.com

Tom Capizzi

Bruce Binkowitz

Hui Quan

Lynn Wei

Xiaohui Luo

Clinical Biostatistics and Research Decision Sciences, RY34-A316, Merck Research Laboratories, Rahway, NJ 07065, USA

To minimize potential controversies in determining the need for multiplicity adjustment for multiple hypotheses, we propose a decision rule based multiplicity adjustment strategy in this paper. Resorting to a predefined decision rule of a clinical trial, one may link the different hypotheses by their logical relationships and divide them into different families. A proper multiplicity adjustment procedure can then be developed by maintaining strong control of Type I error rate within each family. The paper applies the proposed multiplicity adjustment strategy to a published raloxifene clinical trial.

Clinical Trials, Vol. 2, No. 5, 394-399 (2005)
DOI: 10.1191/1740774505cn114oa
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