Jessica E. Becker, AB; Joseph S. Ross, MD, MHS
Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=L14-0306.
Becker JE, Ross JS. Reporting Discrepancies Between the ClinicalTrials.gov Results Database and Peer-Reviewed Publications. Ann Intern Med. 2014;161:760. doi: 10.7326/L14-5022
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Published: Ann Intern Med. 2014;161(10):760.
TO THE EDITOR:
Hartung and colleagues (1) examined a random sample of phase 3 and 4 clinical trials reporting results on Clinical Trials.gov and compared these results with those summarized in corresponding journal publications. They found that the reporting of outcome descriptions, outcome values, and adverse events was highly inconsistent. We did a similar study (2) that had strikingly analogous results, although we explicitly focused on trials registered on Clinical Trials.gov published in high-impact journals.
Hartung and colleagues found that 15% of trials reported discrepant primary outcome descriptions between ClinicalTrials.gov and corresponding publications, whereas 20% inconsistently reported primary outcome values. We found that 15% of primary outcomes were described inconsistently between ClinicalTrials.gov and corresponding publications and 16% of similar primary result values were discordant between the 2 sources.
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