Ensuring safety, implementation and scientific integrity of clinical trials: lessons from the Criminal Justice–Drug Abuse Treatment Studies Data and Safety Monitoring Board

Abstract

Data and safety monitoring boards (DSMBs) provide independent oversight to bio-medical clinical trials, ensuring safe and ethical treatment of research participants, data quality, and credibility of study findings. Recently, the type of research monitored by DSMBs has been expanded to include randomized clinical trials of behavioral and psychosocial interventions in community and justice based settings. This paper focuses on the development and role of a DSMB created by the National Institute on Drug Abuse (NIDA) to monitor six multi-site clinical trials conducted within the Criminal Justice–Drug Abuse Treatment Studies (CJ-DATS). We believe this is one of the first such applications of formal DSMBs in justice settings. Special attention is given to developing processes for measuring and monitoring a range of implementation issues for research conducted within criminal justice settings. Lessons learned and recommendations to enhance future DSMB work within this area are discussed.