Monitoring the randomized trials of the Women's Health Initiative: the experience of the Data and Safety Monitoring Board.
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.
Wittes
Janet
J
Statistics Collaborative, Washington DC, USA. janet@statcollab.com
Barrett-Connor
Elizabeth
E
Braunwald
Eugene
E
Chesney
Margaret
M
Cohen
Harvey Jay
HJ
Demets
David
D
Dunn
Leo
L
Dwyer
Johanna
J
Heaney
Robert P
RP
Vogel
Victor
V
Walters
Leroy
L
Yusuf
Salim
S
D002118:Calcium / Q000627:therapeutic use; D002318:Cardiovascular Diseases / Q000139:chemically induced / Q000517:prevention & control; D026661:Clinical Trials Data Monitoring Committees / Q000458:organization & administration*; D003627:Data Interpretation, Statistical; D019587:Dietary Supplements; D015914:Estrogen Replacement Therapy; D004967:Estrogens / Q000627:therapeutic use; D005260:Female; D006801:Humans; D045167:Progesterone Congeners / Q000627:therapeutic use; D016032:Randomized Controlled Trials as Topic / Q000379:methods* / Q000706:statistics & numerical data*; D012107:Research Design; D018570:Risk Assessment; D014807:Vitamin D / Q000627:therapeutic use; D016387:Women's Health
D004967:Estrogens; D045167:Progesterone Congeners; D014807:Vitamin D; D002118:Calcium