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Strategies for safety reporting in substance abuse trials.

2011 Sep

Journal Article

Lindblad, R.; Campanella, M.; Styers, D.; Kothari, P.; Sparenborg, S.; Rosa, C.

Am J Drug Alcohol Abuse






Drug-Related Side Effects and Adverse Reactions; Humans; National Institute on Drug Abuse (U.S.); Prospective Studies; Randomized Controlled Trials as Topic; Research Design; Retrospective Studies; Risk; Substance-Related Disorders; United States

BACKGROUND: 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.OBJECTIVE: 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.METHODS: We developed a new strategy to standardize safety reporting and tailor reporting to the trial intervention risk. Protocols and safety data from 17 SUD clinical trials were reviewed. Retrospective analysis of five of these studies and prospective application to new studies is described.RESULTS: 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.CONCLUSION: 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.SCIENTIFIC SIGNIFICANCE: 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.

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