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Open Access 01-12-2020 | Research

Consistency of trial reporting between ClinicalTrials.gov and corresponding publications: one decade after FDAAA

Authors: Ramtin Talebi, Rita F. Redberg, Joseph S. Ross

Published in: Trials | Issue 1/2020

Abstract

The FDA Amendments Act (FDAAA) required that information for certain clinical trials, such as details about study design features and endpoints, as well as results, be publicly reported in ClinicalTrials.gov. We conducted a cross-sectional analysis of phase III trials with primary results published between January 1, 2016, and June 30, 2017, in high-impact journals and found 74% contained at least one discrepancy between results reported in ClinicalTrials.gov and the corresponding publication. Our findings underscore the necessity for monitoring of clinical trial information and result reporting between sources; a checklist may provide a systemized procedure for investigators and editors to monitor accurate reporting.

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Food and Drug Administration Amendments Act of 2007. (Public Law No. 110–85 § 801;2007.).

Becker JE, Krumholz HM, Ben-Josef G, Ross JS. Reporting of results in ClinicalTrials.gov and high-impact journals. JAMA. 2014;311(10):1063–5. https://doi.org/10.1001/jama.2013.285634.CrossRefPubMedPubMedCentral

Hartung DM, Zarin DA, Guise J, 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. https://doi.org/10.7326/M13-0480.CrossRefPubMedPubMedCentral

Chen T, Li C, Qin R, et al. Comparison of clinical trial changes in primary outcome and reported intervention effect size between trial registration and publication. JAMA Netw Open. 2019;2(7):e197242. https://doi.org/10.1001/jamanetworkopen.2019.7242.CrossRefPubMedPubMedCentral

Title: Consistency of trial reporting between ClinicalTrials.gov and corresponding publications: one decade after FDAAA
Authors: Ramtin Talebi
Rita F. Redberg
Joseph S. Ross
Publication date: 01-12-2020
Publisher: BioMed Central
Published in: Trials / Issue 1/2020
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-020-04603-9

At a glance: The STEP trials

Springer Medicine

Consistency of trial reporting between ClinicalTrials.gov and corresponding publications: one decade after FDAAA

Abstract

At a glance: The STEP trials

Springer Medicine

Abstract

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