title: Strategies for safety reporting in substance abuse trials.
abstract: 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.
  
  
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: The EMMES Corporation, Rockville, MD, USA. rlindblad@emmes.com
authors.forename: Robert
authors.initials: R
authors.lastname: Lindblad
authors.forename: Maria
authors.initials: M
authors.lastname: Campanella
authors.forename: David
authors.initials: D
authors.lastname: Styers
authors.forename: Prasad
authors.initials: P
authors.lastname: Kothari
authors.forename: Steve
authors.initials: S
authors.lastname: Sparenborg
authors.forename: Carmen
authors.initials: C
authors.lastname: Rosa
mesh_terms: D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D054577:National Institute on Drug Abuse (U.S.); D011446:Prospective Studies; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012107:Research Design; D012189:Retrospective Studies; D012306:Risk; D019966:Substance-Related Disorders / Q000188:drug therapy* / Q000534:rehabilitation; D014481:United States