Decision rule based multiplicity adjustment strategy

Clin Trials. 2005;2(5):394-9. doi: 10.1191/1740774505cn114oa.

Abstract

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.

MeSH terms

  • Bone Density Conservation Agents / therapeutic use
  • Clinical Trials as Topic*
  • Data Interpretation, Statistical
  • Decision Support Techniques*
  • Humans
  • Osteoporosis / drug therapy
  • Raloxifene Hydrochloride / therapeutic use

Substances

  • Bone Density Conservation Agents
  • Raloxifene Hydrochloride