American Journal of Drug and Alcohol Abuse 2011;37(5):440-445. [doi: 10.3109/00952990.2011.602996]
Robert Lindblad, MD, FACEP (EMMES Corporation, CTN Clinical Coordinating Center), Maria Campanella, BSN (EMMES Corporation, CTN Clinical Coordinating Center), David Styers (EMMES Corporation, CTN Clinical Coordinating Center), Prasad Kothari, MS (Synergy Enterprises, Inc.), Steven Sparenborg, PhD (Center for the Clinical Trials Network, NIDA), Carmen L. Rosa, MS (Center for the Clinical Trials Network, NIDA).
Reporting all adverse events (AEs) and serious adverse events (SAEs) in substance use disorder (SUD) clinical trials has yielded limited relevant safety information and has been burdensome to research sites. This article describes a new strategy utilizing standard data elements for AE and SAEs that defines a threshold to reduce unnecessary safety reporting burden in SUD clinical trials and describes retrospective review and prospective preliminary data on the strategy’s safety reporting impact. To develop the new strategy, protocols and safety data from 17 National Drug Abuse Treatment Clinical Trials Network (CTN) protocols were reviewed. Retrospective analysis of five of these studies and prospective application to new studies is described. Results found that, across the 17 previously completed trials, a total of 11,220 AEs and 1330 SAEs were reported in the 6737 participants. Wide variability in AE and SAE reporting rates were noted based on trial type and inconsistent reporting strategies. Application of the new, tailored safety strategy retrospectively and prospectively reduces reporting burden of irrelevant safety events.
Conclusions: Comparison of the previous reporting strategies used in SUD trials to the new strategy demonstrates a more consistent safety system with a reduction in safety reporting burden while maintaining appropriate safety monitoring. Safety assessments should be tailored to the participant risks based on the trial intervention. The current strategies could be applied to safety assessments across all clinical trials in SUDs (both behavioral or pharmacological), reducing burden, improving quality and relevance of safety data collected, and promoting comparability of safety data gathered across similar types of trials. (Article (Peer-Reviewed), PDF, English, 2011)
Keywords: Adverse events | Behavior therapy | CTN platform/ancillary study | Pharmacological therapy | Research design | Safety reporting | American Journal of Drug and Alcohol Abuse (journal)
Document No: 736, PMID: 21854288, NIHMS No.:NIHMS349048
Submitted by CTN Dissemination Librarians, 8/23/2011.