Coordinating Data Monitoring Committees and Adaptive Clinical Trial Designs

Research output: Contribution to journalArticlepeer-review

Abstract

There is a growing interest in employing adaptive clinical trial designs in drug development. Adaptation is usually based on accumulative efficacy data alone. This article examines issues that can arise when an independent data monitoring committee must interface their safety concerns when adaptive changes based on efficacy are taking place. Several types of adaptive changes are examined and the degree of complexity that safety concerns might introduce is discussed. Recommendations are made for sponsor-data monitoring committee communications when the latter has safety concerns that make a particular kind of adaptation inadvisable. Recommendations are made for making adaptive change decisions, minimizing bias, and training DMC and sponsor staff for participation in adaptive design trials.

Original languageEnglish (US)
Pages (from-to)297-301
Number of pages5
JournalTherapeutic Innovation & Regulatory Science
Volume42
Issue number4
DOIs
StatePublished - Jan 1 2008

Keywords

  • Adaptive design
  • Data analysis center
  • Data monitoring committee
  • Internal safety review committee

ASJC Scopus subject areas

  • Pharmacology, Toxicology and Pharmaceutics (miscellaneous)
  • Public Health, Environmental and Occupational Health
  • Pharmacology (medical)

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