Reporting Discrepancies Between the ClinicalTrials.gov Results Database and Peer-Reviewed Publications
Authors: Jessica E. Becker, Joseph S. Ross
Journal: Annals of Internal Medicine (2014)

Letters18 November 2014Reporting Discrepancies Between the ClinicalTrials.gov Results Database and Peer-Reviewed PublicationsJessica E. Becker, AB and Joseph S. Ross, MD, MHSJessica E. Becker, ABFrom Yale University School of Medicine, New Haven, Connecticut. and Joseph S. Ross, MD, MHSFrom Yale University School of Medicine, New Haven, Connecticut.Author, Article, and Disclosure Informationhttps://doi.org/10.7326/L14-5022 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail 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. ...References1. Hartung DM, Zarin DA, Guise JM, McDonagh M, Paynter R, Helfand M. Reporting discrepancies between the ClinicalTrials.gov results database and peer-reviewed publications. Ann Intern Med. 2014;160:477-83. [PMID: 24687070] doi:10.7326/M13-0480 LinkGoogle Scholar2. Becker JE, Krumholz HM, Ben-Josef G, Ross JS. Reporting of results in ClinicalTrials.gov and high-impact journals. JAMA. 2014;311:1063-5. [PMID: 24618969] doi:10.1001/jama.2013.285634 CrossrefMedlineGoogle Scholar Author, Article, and Disclosure InformationAuthors: Jessica E. Becker, AB; Joseph S. Ross, MD, MHSAffiliations: From Yale University School of Medicine, New Haven, Connecticut.Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=L14-0306. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoReporting Discrepancies Between the ClinicalTrials.gov Results Database and Peer-Reviewed Publications Daniel M. Hartung , Deborah A. Zarin , Jeanne-Marie Guise , Marian McDonagh , Robin Paynter , and Mark Helfand Metrics Cited byRisk of pneumonitis in cancer patients treated with PARP inhibitors: A meta-analysis of randomized controlled trials and a pharmacovigilance study of the FAERS databaseTargeted Therapies in Trial for Non-Resectable Gallbladder CancerDiagnostic Clinical Trials in Breast Cancer Brain Metastases: Barriers and Innovations10-Year Update on Study Results Submitted to ClinicalTrials.govCurrent state of clinical trials in breast cancer brain metastasesCurrent State of Hypertrophic Cardiomyopathy Clinical TrialsCurrent status and perspectives of interventional clinical trials for glioblastoma – analysis of ClinicalTrials.govPortfolio of prospective clinical trials including brachytherapy: an analysis of the ClinicalTrials.gov databaseIs research quality in orthopedic manual therapy trials stagnating? Reflections and pathways for improving research quality and advance our professionComparison of serious adverse events posted at ClinicalTrials.gov and published in corresponding journal articles 18 November 2014Volume 161, Issue 10Page: 760KeywordsAdverse eventsClinical trial reportingClinical trialsDatabasesDisclosureFood and Drug AdministrationSerious adverse events ePublished: 18 November 2014 Issue Published: 18 November 2014 Copyright & PermissionsCopyright © 2014 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...