Reporting discrepancies between the results database and peer-reviewed publications

Daniel M. Hartung, Deborah A. Zarin, Jeanne Marie Guise, Marian McDonagh, Robin Paynter, Mark Helfand

Research output: Contribution to journalArticlepeer-review

157 Scopus citations


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 industrysponsored, 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.

Original languageEnglish (US)
Pages (from-to)477-483
Number of pages7
JournalAnnals of internal medicine
Issue number7
StatePublished - Apr 1 2014

ASJC Scopus subject areas

  • Internal Medicine


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