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Group sequential Holm and Hochberg procedures.

Ajit C Tamhane1, Dong Xi2, Jiangtao Gou3

  • 1Department of Industrial Engineering & Management Sciences, Northwestern University, Evanston, Illinois, USA.

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|October 12, 2021
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Summary
This summary is machine-generated.

This study compares group sequential Holm (GSHM) and Hochberg (GSHC) procedures for multiple hypothesis testing in clinical trials. The novel GSHC procedure offers better familywise error rate control and increased statistical power.

Keywords:
Lan and DeMets flexible boundaryO'Brien-Fleming boundaryPocock boundaryclosed procedureerror spending functionfamilywise error ratemultiple hypothesis testing

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Area of Science:

  • Biostatistics
  • Clinical Trial Design
  • Statistical Methods

Background:

  • Group sequential procedures are essential for interim analyses in clinical trials.
  • Testing multiple hypotheses efficiently while controlling error rates is a significant challenge.

Purpose of the Study:

  • To review and clarify relationships between existing group sequential Holm (GSHM) procedures.
  • To propose and evaluate a novel step-up group sequential Hochberg (GSHC) procedure.

Main Methods:

  • Literature review of GSHM procedures.
  • Development of a step-up GSHC procedure.
  • Extensive simulation studies to assess familywise error rate (FWER) and power.
  • Illustration with numerical and real case studies.

Main Results:

  • The proposed GSHC procedure demonstrates superior FWER control compared to GSHM.
  • The GSHC procedure exhibits higher statistical power than comparable GSHM methods.
  • Equivalencies and differences between various GSHM procedures are elucidated.

Conclusions:

  • The GSHC procedure is a powerful and reliable method for multiple hypothesis testing in group sequential clinical trials.
  • The findings provide valuable guidance for selecting appropriate statistical procedures in clinical research.