Industry, government, and academic panel discussion on multiple comparisons in a "real" phase three clinical trial

Peter Bauer, George Chi, Nancy Geller, A. Lawrence Gould, David Jordan, Surya Mohanty, Robert O'Neill, Peter H. Westfall

Research output: Contribution to journalArticlepeer-review

8 Scopus citations

Abstract

A Food and Drug Administration (FDA)/Industry/Academic Panel Discussion on multiplicity aspects of a real Phase III clinical trial was held at the Third International Conference on Multiple Comparisons, August 6, 2002, in Bethesda, Maryland. The goal was to develop some consensus among industry, government, and academic statisticians concerning requirements and methods for multiplicity management in typical clinical trials. The session was tape-recorded; this article mostly comes from an edited transcript.

Original languageEnglish
Pages (from-to)691-701
Number of pages11
JournalJournal of Biopharmaceutical Statistics
Volume13
Issue number4
DOIs
StatePublished - 2003

Keywords

  • Closed testing procedure
  • Efficacy
  • Multiple endpoints
  • Multiple treatment arms
  • Noninferiority testing
  • Protocol
  • Safety
  • Superiority testing

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