title: The data and safety monitoring board and acquired immune deficiency syndrome (AIDS) clinical trials.
abstract: The urgency of the Acquired immune deficiency syndrome (AIDS) epidemic has mandated that multiple therapeutic approaches be developed and that these approaches be evaluated through clinical trials. To oversee these trials, the National Institute of Allergy and Infectious Diseases (NIAID) has created three large clinical trial programs monitored by a Data and Safety Monitoring Board (DSMB). For each clinical trial, this Board uses a standardized approach employing contemporary biostatistical, medical, and ethical principles. The DSMB is responsible for reviewing interim data on clinical trial performance, treatment safety and efficacy, and overall study progress. If interim results provide convincing evidence of either excessive adverse effects or significant treatment benefit, the DSMB may recommend early termination of the trial to the NIAID and the study investigators. The responsibility, organization, and operating procedures of this DSMB are presented and illustrated through three clinical trials sponsored by NIAID and monitored by the Board. The rationale and operational model for the DSMB may be a useful example for the development of similar review processes in other HIV clinical trial settings.
authors.affiliation: Department of Biostatistics, University of Wisconsin Medical School, Madison 53792, USA.
authors.forename: D L
authors.initials: DL
authors.lastname: DeMets
authors.forename: T R
authors.initials: TR
authors.lastname: Fleming
authors.forename: R J
authors.initials: RJ
authors.lastname: Whitley
authors.forename: J F
authors.initials: JF
authors.lastname: Childress
authors.forename: S S
authors.initials: SS
authors.lastname: Ellenberg
authors.forename: M
authors.initials: M
authors.lastname: Foulkes
authors.forename: K H
authors.initials: KH
authors.lastname: Mayer
authors.forename: J
authors.initials: J
authors.lastname: O'Fallon
authors.forename: R B
authors.initials: RB
authors.lastname: Pollard
authors.forename: J J
authors.initials: JJ
authors.lastname: Rahal
mesh_terms: D026683:Advisory Committees; D000890:Anti-Infective Agents / Q000627:therapeutic use; D026661:Clinical Trials Data Monitoring Committees; D002986:Clinical Trials as Topic / Q000592:standards*; D003219:Confidentiality; D016265:Conflict of Interest; D016049:Didanosine / Q000627:therapeutic use; D004341:Drug Evaluation / Q000592:standards*; D035082:Federal Government; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D009316:National Institutes of Health (U.S.) / Q000592:standards*; D009937:Organizational Objectives; D011367:Professional Staff Committees / Q000458:organization & administration*; D011739:Pyrimethamine / Q000627:therapeutic use; D018894:Reverse Transcriptase Inhibitors / Q000627:therapeutic use; D018570:Risk Assessment; D016781:Toxoplasmosis, Cerebral / Q000517:prevention & control; D016896:Treatment Outcome; D014481:United States; D016047:Zalcitabine / Q000627:therapeutic use; D015215:Zidovudine / Q000627:therapeutic use
chemical_list: D000890:Anti-Infective Agents; D018894:Reverse Transcriptase Inhibitors; D015215:Zidovudine; D016047:Zalcitabine; D016049:Didanosine; D011739:Pyrimethamine