Reporting discrepancies between the results database and peer-reviewed publications

Ann Intern Med. 2014 Apr 1;160(7):477-83. doi: 10.7326/M13-0480.


Background: requires reporting of result summaries for many drug and device trials.

Purpose: To evaluate the consistency of reporting of trials that are registered in the results database and published in the literature.

Data sources: results database and matched publications identified through and a manual search of 2 electronic databases.

Study selection: 10% random sample of phase 3 or 4 trials with results in the results database, completed before 1 January 2009, with 2 or more groups.

Data extraction: One reviewer extracted data about trial design and results from the results database and matching publications. A subsample was independently verified.

Data synthesis: Of 110 trials with results, most were industry-sponsored, parallel-design drug studies. The most common inconsistency was the number of secondary outcome measures reported (80%). Sixteen trials (15%) reported the primary outcome description inconsistently, and 22 (20%) reported the primary outcome value inconsistently. Thirty-eight trials inconsistently reported the number of individuals with a serious adverse event (SAE); of these, 33 (87%) reported more SAEs in Among the 84 trials that reported SAEs in, 11 publications did not mention SAEs, 5 reported them as zero or not occurring, and 21 reported a different number of SAEs. Among 29 trials that reported deaths in, 28% differed from the matched publication.

Limitation: Small sample that included earliest results posted to the database.

Conclusion: Reporting discrepancies between the results database and matching publications are common. Which source contains the more accurate account of results is unclear, although may provide a more comprehensive description of adverse events than the publication.

Primary funding source: Agency for Healthcare Research and Quality.

Publication types

  • Research Support, N.I.H., Extramural
  • Research Support, N.I.H., Intramural

MeSH terms

  • Clinical Trials as Topic / standards*
  • Databases, Factual / standards*
  • Drug-Related Side Effects and Adverse Reactions
  • Humans
  • Peer Review, Research / standards*