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Issues in regulatory guidelines for data monitoring committees

Department of Biostatistics and Medical Informatics, University of Wisconsin, 600 Highland Avenue, Box 4675, Madison, WI 53792-4675, USAdemets{at}biostat.wisc.edu

Robert Califf

Duke Clinical Research Institute, Durham, NC, USA

Dennis Dixon

National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA

Susan Ellenberg

US Food and Drug Administration, Rockville, MD, USA

Thomas Fleming

University of Washington, Seattle, WA, USA

Peter Held

AstraZeneca, Molndal, Sweden

Desmond Julian

University of Newcastle-upon-Tyne, UK

Richard Kaplan

National Cancer Institute, Bethesda, MD, USA

Robert Levine

Yale University, New Haven, CT, USA

James Neaton

University of Minnesota, Minneapolis, MN, USA

Milton Packer

Columbia University, New York, NY, USA

Stuart Pocock

London School of Hygiene and Tropical Medicine, London, UK

Frank Rockhold

GlaxoSmith Kline, King of Prussia, PA, USA

Belinda Seto

National Institutes of Health, Bethesda, MD, USA

Jay Siegel

Centocor, Malver, PA, USA

Steve Snapinn

Merck Research Labs, Blue Bell, PA, USA

David Stump

Human Genome Sciences, Inc., Rockville, MD, USA

Robert Temple

US Food and Drug Administration, Rockville, MD, USA

Richard Whitley

University of Alabama, Birmingham, AL, USA

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.

Clinical Trials, Vol. 1, No. 2, 162-169 (2004)
DOI: 10.1191/1740774504cn019xx


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