Reporting discrepancies between the ClinicalTrials.gov results database and peer-reviewed publications

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

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Abstract

Background: ClinicalTrials.gov 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 ClinicalTrials.gov results database and published in the literature. Data Sources: ClinicalTrials.gov results database and matched publications identified through ClinicalTrials.gov and a manual search of 2 electronic databases. Study Selection: 10% random sample of phase 3 or 4 trials with results in the ClinicalTrials.gov 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 ClinicalTrials.gov. Among the 84 trials that reported SAEs in ClinicalTrials.gov, 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 ClinicalTrials.gov, 28% differed from the matched publication. Limitation: Small sample that included earliest results posted to the database. Conclusion: Reporting discrepancies between the ClinicalTrials.gov results database and matching publications are common. Which source contains the more accurate account of results is unclear, although ClinicalTrials.gov 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
Volume160
Issue number7
StatePublished - Apr 1 2014

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Reporting discrepancies between the ClinicalTrials.gov results database and peer-reviewed publications. / Hartung, Daniel M.; Zarin, Deborah A.; Guise, Jeanne-Marie; McDonagh, Marian; Paynter, Robin; Helfand, Mark.

In: Annals of Internal Medicine, Vol. 160, No. 7, 01.04.2014, p. 477-483.

Research output: Contribution to journalArticle

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abstract = "Background: ClinicalTrials.gov 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 ClinicalTrials.gov results database and published in the literature. Data Sources: ClinicalTrials.gov results database and matched publications identified through ClinicalTrials.gov and a manual search of 2 electronic databases. Study Selection: 10{\%} random sample of phase 3 or 4 trials with results in the ClinicalTrials.gov 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 ClinicalTrials.gov. Among the 84 trials that reported SAEs in ClinicalTrials.gov, 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 ClinicalTrials.gov, 28{\%} differed from the matched publication. Limitation: Small sample that included earliest results posted to the database. Conclusion: Reporting discrepancies between the ClinicalTrials.gov results database and matching publications are common. Which source contains the more accurate account of results is unclear, although ClinicalTrials.gov may provide a more comprehensive description of adverse events than the publication.",
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