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, Le Roy Walters, Salim Yusuf

Research output: Contribution to journalArticle

32 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)218-234
Number of pages17
JournalClinical Trials
Volume4
Issue number3
DOIs
StatePublished - Sep 19 2007

All Science Journal Classification (ASJC) codes

  • Pharmacology

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    Wittes, J., Barrett-Connor, E., Braunwald, E., Chesney, M., Cohen, H. J., DeMets, D., Dunn, L., Dwyer, J., Heaney, R. P., Vogel, V., Walters, L. R., & Yusuf, S. (2007). Monitoring the randomized trials of the Women's Health Initiative: The experience of the Data and Safety Monitoring Board. Clinical Trials, 4(3), 218-234. https://doi.org/10.1191/1740774507079439