Monitoring the randomized trials of the Women's Health Initiative: the experience of the Data and Safety Monitoring Board

Author:

Wittes Janet1,Barrett-Connor Elizabeth2,Braunwald Eugene3,Chesney Margaret4,Cohen Harvey Jay5,DeMets David6,Dunn Leo7,Dwyer Johanna8,Heaney Robert P.9,Vogel Victor10,Walters LeRoy11,Yusuf Salim12

Affiliation:

1. Statistics Collaborative, Washington DC, USA,

2. University of California, San Diego, California, USA

3. Harvard Medical School, Boston, Massachusetts, USA

4. National Center for Complementary and Alternative Medicine, Bethesda, Maryland, USA

5. Duke University Medical School, Durham, North Carolina, USA

6. University of Wisconsin, Madison, Wisconsin, USA

7. Virginia Commonwealth University, Richmond, Virginia, USA

8. National Institutes of Health, Bethesda, Maryland, USA

9. Creighton University, Omaha, Nebraska, USA

10. University of Pittsburgh, Pittsburgh, Pennsylvania, USA

11. Georgetown University, Washington DC, USA

12. McMaster University, Hamilton, Ontario, Canada

Abstract

Data Safety Monitoring Committees (DSMB) for large, long-term randomized trials of agents in common use face challenging problems especially when the emerging data indicate unanticipated effects. The DSMB for the Women's Health Initiative Clinical Trials, on observing early indication of a surprising adverse cardiovascular effect of post-menopausal hormones, spent several years deliberating what recommendations it should make. This paper describes the dilemmas faced by the DSMB and the considerations it made over the course of its existence. The paper concludes with some recommendations for other DSMBs.

Publisher

SAGE Publications

Subject

Pharmacology,General Medicine

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