Issues in regulatory guidelines for data monitoring committees

Author:

DeMets David1,Califf Robert2,Dixon Dennis3,Ellenberg Susan4,Fleming Thomas5,Held Peter6,Julian Desmond7,Kaplan Richard8,Levine Robert9,Neaton James10,Packer Milton11,Pocock Stuart12,Rockhold Frank13,Seto Belinda14,Siegel Jay15,Snapinn Steve16,Stump David17,Temple Robert4,Whitley Richard18

Affiliation:

1. Department of Biostatistics and Medical Informatics, University of Wisconsin, 600 Highland Avenue, Box 4675, Madison, WI 53792-4675, USA

2. Duke Clinical Research Institute, Durham, NC, USA

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

4. US Food and Drug Administration, Rockville, MD, USA

5. University of Washington, Seattle, WA, USA

6. AstraZeneca, Molndal, Sweden

7. University of Newcastle-upon-Tyne, UK

8. National Cancer Institute, Bethesda, MD, USA

9. Yale University, New Haven, CT, USA

10. University of Minnesota, Minneapolis, MN, USA

11. Columbia University, New York, NY, USA

12. London School of Hygiene and Tropical Medicine, London, UK

13. GlaxoSmith Kline, King of Prussia, PA, USA

14. National Institutes of Health, Bethesda, MD, USA

15. Centocor, Malver, PA, USA

16. Merck Research Labs, Blue Bell, PA, USA

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

18. University of Alabama, Birmingham, AL, USA

Abstract

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.

Publisher

SAGE Publications

Subject

Pharmacology,General Medicine

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