Three Methods for Constructing Parallel Gatekeeping Procedures in Clinical Trials

Abstract

This paper gives a review of three classes of parallel gatekeeping procedures that can be used in clinical trials with multiple objectives grouped into two or more families. We begin with a high-level summary of three methods for building parallel gatekeeping procedures proposed in the literature and provide a detailed comparison of the three methods. The comparison is based on analytical arguments as well as simulation studies and helps us develop general recommendations on the use of these methods in clinical trial applications. The methods discussed in this paper are illustrated using clinical trial examples with two families of objectives.

Key Words:

• Clinical trials
• Familywise error rate
• Multiple tests
• Power