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

Janet Wittes, Elizabeth Barrett-Connor, Eugene Braunwald, Margaret Chesney, Harvey Jay Cohen, David Demets, Leo Dunn, Johanna Dwyer, Robert P Heaney, Victor Vogel, Leroy Walters, Salim Yusuf

Journal: Clinical trials (London, England) 2007;4(3):218-34

PMID: 17715247

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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.

Address: Statistics Collaborative, Washington DC, USA. [email protected]

DOI: 10.1177/1740774507079439

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MeSH Terms: Calcium, Cardiovascular Diseases, Clinical Trials Data Monitoring Committees, Data Interpretation, Statistical, Dietary Supplements, Estrogen Replacement Therapy, Estrogens, Female, Humans, Progesterone Congeners, Randomized Controlled Trials as Topic, Research Design, Risk Assessment, Vitamin D, Women's Health