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

Published

Journal Article

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.

Full Text

Duke Authors

Cited Authors

  • Wittes, J; Barrett-Connor, E; Braunwald, E; Chesney, M; Cohen, HJ; Demets, D; Dunn, L; Dwyer, J; Heaney, RP; Vogel, V; Walters, L; Yusuf, S

Published Date

  • 2007

Published In

Volume / Issue

  • 4 / 3

Start / End Page

  • 218 - 234

PubMed ID

  • 17715247

Pubmed Central ID

  • 17715247

International Standard Serial Number (ISSN)

  • 1740-7745

Digital Object Identifier (DOI)

  • 10.1177/1740774507079439

Language

  • eng

Conference Location

  • England