Issues in regulatory guidelines for data monitoring committees.


Journal Article (Review)

As clinical trials have emerged as the major research method for evaluating new interventions, the process for monitoring intervention safety and benefit has also evolved. The Data Monitoring Committee (DMC) has become the standard approach to implement this responsibility for many Phase III trials. Recent draft guidelines on the operation of DMCs by the Food and Drug Administration (FDA) have raised issues that need further clarification or discussion, especially for industry sponsored trials. These include, the time when DMCs are needed, the role of the independent statistician to support the DMC, and sponsor participation at DMC meetings. This paper provides an overview of these issues, based on the discussions at the January, 2003 workshop sponsored by Duke Clinical Research Institute.

Full Text

Duke Authors

Cited Authors

  • DeMets, D; Califf, R; Dixon, D; Ellenberg, S; Fleming, T; Held, P; Julian, D; Kaplan, R; Levine, R; Neaton, J; Packer, M; Pocock, S; Rockhold, F; Seto, B; Siegel, J; Snapinn, S; Stump, D; Temple, R; Whitley, R

Published Date

  • 2004

Published In

Volume / Issue

  • 1 / 2

Start / End Page

  • 162 - 169

PubMed ID

  • 16281888

Pubmed Central ID

  • 16281888

International Standard Serial Number (ISSN)

  • 1740-7745

Digital Object Identifier (DOI)

  • 10.1191/1740774504cn019xx


  • eng

Conference Location

  • England