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Monitoring the randomized trials of the Women's Health Initiative: the experience of the Data and Safety Monitoring BoardStatistics Collaborative, Washington DC, USA, janet{at}statcollab.com
University of California, San Diego, California, USA
Harvard Medical School, Boston, Massachusetts, USA
National Center for Complementary and Alternative Medicine, Bethesda, Maryland, USA
Duke University Medical School, Durham, North Carolina, USA
University of Wisconsin, Madison, Wisconsin, USA
Virginia Commonwealth University, Richmond, Virginia, USA
National Institutes of Health, Bethesda, Maryland, USA
Creighton University, Omaha, Nebraska, USA
University of Pittsburgh, Pittsburgh, Pennsylvania, USA
Georgetown University, Washington DC, USA
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.
Clinical Trials, Vol. 4, No. 3,
218-234 (2007) This article has been cited by other articles:
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