Standardizing and streamlining safety reporting in substance abuse trials.

Safety reporting in psychosocial trials is controversial. Reporting of all adverse events yields limited relevant safety information and is burdensome to clinical sites. Since 1999, the National Institute of Drug Abuse’s National Drug Abuse Treatment Clinical Trial Network (CTN) has conducted 24 randomized clinical trials in the field of drug abuse. Safety reporting was variable reflecting the numerous investigator’s and data center’s variety of prior experience and study type. In 2004 the CTN created a centralized safety office. Several distinct entities with a vested interest in safety reporting including the sponsor, the Institutional Review Board, a Data Safety Monitoring Board and the Food and Drug Administration, impact safety reporting strategies. We describe strategies to standardize safety data collection, reduce site reporting burden, problems encountered and maintain appropriate safety monitoring.

Protocols and safety data from the 17 completed trials available from the CTN public data share web site were reviewed. A total of 11,302 AEs and 1,330 SAEs were reported across approximately 6,700 participants enrolled in three investigational pharmaceutical intervention, one combination investigational pharmaceutical / psychosocial intervention, one combination marketed pharmaceutical / psychosocial intervention and twelve psychosocial intervention alone. Safety reporting variability resulted in problematic across-study comparisons. Since 2004 the safety office has instituted systematic processes to standardize safety reporting including consistent definitions and characterizations of adverse events and serious adverse events and clearly defining in the protocol which identified events require reporting in the central data base. Driven by lessons learned, the current strategies were developed to standardize adverse event reporting, support cross study comparisons, reduce reporting burden for clinical sites and preserve appropriate safety monitoring of clinical trial participants.