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

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.

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@article{Wittes2007MonitoringTR, title={Monitoring the randomized trials of the Women's Health Initiative: the experience of the Data and Safety Monitoring Board.}, author={Janet T Wittes and Elizabeth Barrett-Connor and Eugene Braunwald and M. A. Chesney and Harvey J. Cohen and David DeMets and Leo Dunn and Johanna Dwyer and Robert P . Heaney and Victor G. Vogel and Leroy Walters and Salim Yusuf}, journal={Clinical trials}, year={2007}, volume={4 3}, pages={218-34} }