The Data and Safety Monitoring Board and Acquired immune deficiency syndrome (AIDS) clinical trials
Year: 1995
Type: article
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.
Source: Controlled Clinical Trials
Institutions: University of Wisconsin–Madison, University of Washington, University of Alabama at Birmingham, University of Virginia, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Memorial Hospital of Rhode Island, Mayo Clinic, The University of Texas Medical Branch at Galveston, Albert Einstein College of Medicine, New York Hospital Queens, San Francisco General Hospital, Georgetown University, Rutgers, The State University of New Jersey
Language: English
Topic: Ethics in Clinical Research
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
OpenAlex ID: W2089805696