THE DATA AND SAFETY MONITORING BOARD AND ACQUIRED-IMMUNE-DEFICIENCY-SYNDROME (AIDS) CLINICAL-TRIALS

The urgency of the Acquired immune deficiency syndrome (AIDS) epidemic has mandated that multiple therapeutic approaches be developed and th at these approaches be evaluated through clinical trials. To oversee t hese 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, th is Board uses a standardized approach employing contemporary biostatis tical, medical, and ethical principles. The DSMB is responsible for re viewing interim data on clinical trial performance, treatment safety a nd efficacy, and overall study progress. If interim results provide co nvincing evidence of either excessive adverse effects or significant t reatment benefit, the DSMB may recommend early termination of the tria l to the NIAID and the study investigators. The responsibility, organi zation, and operating procedures of this DSMB are presented and illust rated through three clinical trials sponsored by NIAID and monitored b y the Board. The rationale and operational model for the DSMB may be a useful example for the development of similar review processes in oth er HIV clinical trial settings.