title: Adverse event assessment methods in published trials of psychotropic drugs: Poor reporting and neglect of emerging safety concerns.
abstract: BACKGROUND
  Actual assessment methods for identifying adverse events (AEs) in clinical trials have received less scrutiny than underreporting of AEs.
  
  
  OBJECTIVE
  To investigate whether AE assessment has changed over time for three psychotropic drugs with turbulent histories of safety concerns since their U.S. approval.
  
  
  METHODS
  From industry-funded published trials of atomoxetine, duloxetine, and olanzapine retrieved from PubMed for 1996-2004 (n = 33) and 2009-2014 (n = 40), verbatim AE assessment and numbers of words describing efficacy and safety assessment were extracted.
  
  
  RESULTS
  Closest to drug approval (1996-2004), 77.8% of atomoxetine trials used open-ended questioning only, 50% of duloxetine trials used spontaneous self-report or clinician observation only, and 66.7% of olanzapine trials used a scale (primarily for extrapyramidal symptoms) and one former method. Recent studies (2009-2014) showed less rigor and transparency: 35.3% of atomoxetine and 64.7% of duloxetine studies reported no AE assessment method and 50% of olanzapine studies no longer used scales. Overall, the mean number of words describing efficacy assessment increased from 202 to 309 but decreased from 83 to 63 for safety.
  
  
  CONCLUSIONS
  Trial methodology for assessing psychotropic drug safety remains an underdeveloped area with major public health implications.
authors: School of Social Work, College of Health and Human Sciences, Colorado State University, Fort Collins, CO, USA.
authors: Shannon
authors: S
authors: Hughes
authors: Luskin School of Public Affairs, University of California, Los Angeles, CA, USA.
authors: David
authors: D
authors: Cohen
authors: Milwaukee, WI, USA.
authors: Rebekah
authors: R
authors: Johnson
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000592:standards / Q000706:statistics & numerical data; D002986:Clinical Trials as Topic / Q000379:methods / Q000592:standards; D030881:Disclosure; D064420:Drug-Related Side Effects and Adverse Reactions / Q000175:diagnosis* / Q000209:etiology; D006801:Humans; D020380:Needs Assessment; D063868:Patient Outcome Assessment; D011619:Psychotropic Drugs / Q000009:adverse effects*; D058996:Quality Improvement; D012107:Research Design / Q000592:standards
chemical_list: D011619:Psychotropic Drugs
keywords: Drug safety; adverse events; clinical trial methodology; psychotropic drugs