title: Differences in reporting serious adverse events in industry sponsored clinical trial registries and journal articles on antidepressant and antipsychotic drugs: a cross-sectional study.
abstract: OBJECTIVE
  To examine the degree of concordance in reporting serious adverse events (SAEs) from antidepressant and antipsychotic drug trials among journal articles and clinical trial summaries, and to categorise types of discrepancies.
  
  
  METHODS
  Cross-sectional study of summaries of all antidepressant and antipsychotic trials included in an online trial registry and their first associated stand-alone journal articles.
  
  
  METHODS
  Clinicalstudyresults.org, sponsored by Pharmaceutical Research and Manufacturers of America; clinicaltrials.gov, administered by the US National Institutes of Health.
  
  
  METHODS
  3 coders extracted data on the numbers and types of SAEs.
  
  
  RESULTS
  244 trial summaries for six antidepressant and antipsychotic drugs were retrieved, 142 (58.2%) listing an associated article. Of 1608 SAEs in drug-treated participants according to trial summaries, 694 (43.2%) did not appear in associated articles. Nearly 60% of SAEs counted in articles and 41% in trial summaries had no description. Most cases of death (62.3%) and suicide (53.3%) were not reported in articles. Half or more of the 142 pairs were discordant in reporting the number (49.3%) or description (67.6%) of SAEs. These discrepancies resulted from journal articles' (1) omission of complete SAE data, (2) reporting acute phase study results only and (3) more restrictive reporting criteria. Trial summaries with zero SAE were 2.35 (95% CI, 1.58 to 3.49; p<0.001) times more likely to be published with no discrepancy in their associated journal article. Since clinicalstudyresults.org was removed from the Internet in 2011, only 7.8% of retrieved trial summaries appear with results on clinicaltrials.gov.
  
  
  CONCLUSIONS
  Substantial discrepancies exist in SAE data found in journal articles and registered summaries of antidepressant and antipsychotic drug trials. Two main scientific sources accessible to clinicians and researchers are limited by incomplete, ambiguous and inconsistent reporting. Access to complete and accurate data from clinical trials of drugs currently in use remains a pressing concern.
authors.affiliation: School of Social Work, Colorado State University, Fort Collins, Colorado, USA.
authors.forename: Shannon
authors.initials: S
authors.lastname: Hughes
authors.affiliation: Luskin School of Public Affairs, University of California, Los Angeles, California, USA.
authors.forename: David
authors.initials: D
authors.lastname: Cohen
authors.affiliation: University of Utah, Salt Lake City, Utah, USA.
authors.forename: Rachel
authors.initials: R
authors.lastname: Jaggi
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data*; D000928:Antidepressive Agents / Q000009:adverse effects*; D014150:Antipsychotic Agents / Q000009:adverse effects*; D002986:Clinical Trials as Topic; D003430:Cross-Sectional Studies; D004345:Drug Industry; D006801:Humans; D010506:Periodicals as Topic; D012042:Registries; D012720:Severity of Illness Index
chemical_list: D000928:Antidepressive Agents; D014150:Antipsychotic Agents
keywords: CLINICAL PHARMACOLOGY