Does information from ClinicalTrials.gov increase transparency and reduce bias? Results from a five-report case series Public Deposited

Downloadable Content

Download PDF
Creator
  • Eaton, Jennifer L
    • Other Affiliation: Duke University Evidence-based Practice Center, Durham, USA
  • Adam, Gaelen P
    • Other Affiliation: Brown University Evidence-based Practice Center, Providence, USA
  • Viswanathan, Meera
    • Other Affiliation: RTI/UNC Evidence-based Practice Center, Chapel Hill, USA
  • Springs, Stacey
    • Other Affiliation: Brown University Evidence-based Practice Center, Providence, USA
  • Von Isenburg, Megan
    • Other Affiliation: Duke University Evidence-based Practice Center, Durham, USA
  • Gierisch, Jennifer M
    • Other Affiliation: Duke University Evidence-based Practice Center, Durham, USA
  • Williams, John W
    • Other Affiliation: Duke University Evidence-based Practice Center, Durham, USA
  • Wilson, Lisa M
    • Other Affiliation: Johns Hopkins University Evidence-based Practice Center, Baltimore, USA
  • Kaplan, Robert M
    • Other Affiliation: Stanford University Clinical Excellence Research Center, Stanford, USA
  • Berliner, Elise
    • Other Affiliation: Agency for Healthcare Research and Quality, Rockville, USA
  • Trikalinos, Thomas
    • Other Affiliation: Brown University Evidence-based Practice Center, Providence, USA
  • Middleton, Jennifer C
    • Other Affiliation: RTI/UNC Evidence-based Practice Center, Chapel Hill, USA
  • Robinson, Karen A
    • Other Affiliation: Johns Hopkins University Evidence-based Practice Center, Baltimore, USA
  • Forman-Hoffman, Valerie L
    • Other Affiliation: RTI/UNC Evidence-based Practice Center, Chapel Hill, USA
Abstract
  • Abstract Background We investigated whether information in ClinicalTrials.gov would impact the conclusions of five ongoing systematic reviews. Method We considered five reviews that included 495 studies total. Each review team conducted a search of ClinicalTrials.gov up to the date of the review’s last literature search, screened the records using the review’s eligibility criteria, extracted information, and assessed risk of bias and applicability. Each team then evaluated the impact of the evidence found in ClinicalTrials.gov on the conclusions in the review. Results Across the five reviews, the number of studies that had both a registry record and a publication varied widely, from none in one review to 43% of all studies identified in another. Among the studies with both a record and publication, there was also wide variability in the match between published outcomes and those listed in ClinicalTrials.gov. Of the 173 total ClinicalTrials.gov records identified across the five projects, between 11 and 43% did not have an associated publication. In the 14% of records that contained results, the new data provided in the ClinicalTrials.gov records did not change the results or conclusions of the reviews. Finally, a large number of published studies were not registered in ClinicalTrials.gov, but many of these were published before ClinicalTrials.gov’s inception date of 2000. Conclusion Improved prospective registration of trials and consistent reporting of results in ClinicalTrials.gov would help make ClinicalTrials.gov records more useful in finding unpublished information and identifying potential biases. In addition, consistent indexing in databases, such as MEDLINE, would allow for better matching of records and publications, leading to increased utility of these searches for systematic review projects.
Date of publication
Identifier
  • doi:10.1186/s13643-018-0726-5
Resource type
  • Article
Rights statement
  • In Copyright
Rights holder
  • The Author(s).
Language
  • English
Bibliographic citation
  • Systematic Reviews. 2018 Apr 16;7(1):59
Publisher
  • BioMed Central
Parents:

This work has no parents.

Items