title: 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.
authors: Statistics Collaborative, Washington DC, USA. janet@statcollab.com
authors: Janet
authors: J
authors: Wittes
authors: Elizabeth
authors: E
authors: Barrett-Connor
authors: Eugene
authors: E
authors: Braunwald
authors: Margaret
authors: M
authors: Chesney
authors: Harvey Jay
authors: HJ
authors: Cohen
authors: David
authors: D
authors: Demets
authors: Leo
authors: L
authors: Dunn
authors: Johanna
authors: J
authors: Dwyer
authors: Robert P
authors: RP
authors: Heaney
authors: Victor
authors: V
authors: Vogel
authors: Leroy
authors: L
authors: Walters
authors: Salim
authors: S
authors: Yusuf
mesh_terms: 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
chemical_list: D004967:Estrogens; D045167:Progesterone Congeners; D014807:Vitamin D; D002118:Calcium