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

Statistics Collaborative, Washington DC, USA, janet{at}statcollab.com

Elizabeth Barrett-Connor

University of California, San Diego, California, USA

Eugene Braunwald

Harvard Medical School, Boston, Massachusetts, USA

Margaret Chesney

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

Harvey Jay Cohen

Duke University Medical School, Durham, North Carolina, USA

David DeMets

University of Wisconsin, Madison, Wisconsin, USA

Leo Dunn

Virginia Commonwealth University, Richmond, Virginia, USA

Johanna Dwyer

National Institutes of Health, Bethesda, Maryland, USA

Robert P. Heaney

Creighton University, Omaha, Nebraska, USA

Victor Vogel

University of Pittsburgh, Pittsburgh, Pennsylvania, USA

LeRoy Walters

Georgetown University, Washington DC, USA

Salim Yusuf

McMaster University, Hamilton, Ontario, Canada

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.

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