Monitoring the randomized trials of the Women's Health Initiative: the experience of the Data and Safety Monitoring Board.
Publication
, Journal Article
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 in: Clin Trials
2007
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.
Duke Scholars
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Published In
Clin Trials
DOI
ISSN
1740-7745
Publication Date
2007
Volume
4
Issue
3
Start / End Page
218 / 234
Location
England
Related Subject Headings
- Women's Health
- Vitamin D
- Statistics & Probability
- Risk Assessment
- Research Design
- Randomized Controlled Trials as Topic
- Progesterone Congeners
- Humans
- Female
- Estrogens
Citation
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Chicago
ICMJE
MLA
NLM
Wittes, J., Barrett-Connor, E., Braunwald, E., Chesney, M., Cohen, H. J., Demets, D., … Yusuf, S. (2007). Monitoring the randomized trials of the Women's Health Initiative: the experience of the Data and Safety Monitoring Board. Clin Trials, 4(3), 218–234. https://doi.org/10.1177/1740774507079439
Wittes, Janet, Elizabeth Barrett-Connor, Eugene Braunwald, Margaret Chesney, Harvey Jay Cohen, David Demets, Leo Dunn, et al. “Monitoring the randomized trials of the Women's Health Initiative: the experience of the Data and Safety Monitoring Board.” Clin Trials 4, no. 3 (2007): 218–34. https://doi.org/10.1177/1740774507079439.
Wittes J, Barrett-Connor E, Braunwald E, Chesney M, Cohen HJ, Demets D, et al. Monitoring the randomized trials of the Women's Health Initiative: the experience of the Data and Safety Monitoring Board. Clin Trials. 2007;4(3):218–34.
Wittes, Janet, et al. “Monitoring the randomized trials of the Women's Health Initiative: the experience of the Data and Safety Monitoring Board.” Clin Trials, vol. 4, no. 3, 2007, pp. 218–34. Pubmed, doi:10.1177/1740774507079439.
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. Monitoring the randomized trials of the Women's Health Initiative: the experience of the Data and Safety Monitoring Board. Clin Trials. 2007;4(3):218–234.
Published In
Clin Trials
DOI
ISSN
1740-7745
Publication Date
2007
Volume
4
Issue
3
Start / End Page
218 / 234
Location
England
Related Subject Headings
- Women's Health
- Vitamin D
- Statistics & Probability
- Risk Assessment
- Research Design
- Randomized Controlled Trials as Topic
- Progesterone Congeners
- Humans
- Female
- Estrogens