The Data and Safety Monitoring Board and Acquired immune deficiency syndrome (AIDS) clinical trials

David L. DeMets, Thomas R. Fleming, Richard J. Whitley, James F. Childress, Susan S. Ellenberg, Mary Foulkes, Kenneth H. Mayer, Judith O'Fallon, Richard B Pollard, James J. Rahal, Merle Sande, Stephen Straus, LeRoy Walters, Patricia Whitley-Williams

Research output: Contribution to journalArticle

38 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)408-421
Number of pages14
JournalControlled Clinical Trials
Volume16
Issue number6
DOIs
StatePublished - 1995
Externally publishedYes

Keywords

  • AIDS clinical trials
  • DSMBs

ASJC Scopus subject areas

  • Pharmacology

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    DeMets, D. L., Fleming, T. R., Whitley, R. J., Childress, J. F., Ellenberg, S. S., Foulkes, M., Mayer, K. H., O'Fallon, J., Pollard, R. B., Rahal, J. J., Sande, M., Straus, S., Walters, L., & Whitley-Williams, P. (1995). The Data and Safety Monitoring Board and Acquired immune deficiency syndrome (AIDS) clinical trials. Controlled Clinical Trials, 16(6), 408-421. https://doi.org/10.1016/S0197-2456(95)00073-9