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

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...

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Detalles Bibliográficos
Autores principales: Talebi, Ramtin, Redberg, Rita F., Ross, Joseph S.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2020
Materias:
Research
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7376878/
https://www.ncbi.nlm.nih.gov/pubmed/32703252
http://dx.doi.org/10.1186/s13063-020-04603-9
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author Talebi, Ramtin
Redberg, Rita F.
Ross, Joseph S.
author_facet Talebi, Ramtin
Redberg, Rita F.
Ross, Joseph S.
author_sort Talebi, Ramtin
collection PubMed
description 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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spelling pubmed-73768782020-07-23 Consistency of trial reporting between ClinicalTrials.gov and corresponding publications: one decade after FDAAA Talebi, Ramtin Redberg, Rita F. Ross, Joseph S. Trials Research 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. BioMed Central 2020-07-23 /pmc/articles/PMC7376878/ /pubmed/32703252 http://dx.doi.org/10.1186/s13063-020-04603-9 Text en © The Author(s) 2020 Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Research
Talebi, Ramtin
Redberg, Rita F.
Ross, Joseph S.
Consistency of trial reporting between ClinicalTrials.gov and corresponding publications: one decade after FDAAA
title Consistency of trial reporting between ClinicalTrials.gov and corresponding publications: one decade after FDAAA
title_full Consistency of trial reporting between ClinicalTrials.gov and corresponding publications: one decade after FDAAA
title_fullStr Consistency of trial reporting between ClinicalTrials.gov and corresponding publications: one decade after FDAAA
title_full_unstemmed Consistency of trial reporting between ClinicalTrials.gov and corresponding publications: one decade after FDAAA
title_short Consistency of trial reporting between ClinicalTrials.gov and corresponding publications: one decade after FDAAA
title_sort consistency of trial reporting between clinicaltrials.gov and corresponding publications: one decade after fdaaa
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7376878/
https://www.ncbi.nlm.nih.gov/pubmed/32703252
http://dx.doi.org/10.1186/s13063-020-04603-9
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