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Cited by 381Pharmaceutical industry and healthcareAcademic Publishing and Open AccessMeta-analysis and systematic reviews

Compliance with Results Reporting at ClinicalTrials.gov

Open access
Anderson, Monique L., Chiswell, Karen, Peterson, Eric D., Tasneem, Asba, Topping, James, Califf, Robert M.·2015·New England Journal of Medicine
DOI 10.1056/nejmsa1409364PMC PMC4508873
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Abstract

BACKGROUND: The Food and Drug Administration Amendments Act (FDAAA) mandates timely reporting of results of applicable clinical trials to ClinicalTrials.gov. We characterized the proportion of applicable clinical trials with publicly available results and determined independent factors associated with the reporting of results. METHODS: Using an algorithm based on input from the National Library of Medicine, we identified trials that were likely to be subject to FDAAA provisions (highly likely applicable clinical trials, or HLACTs) from 2008 through 2013. We determined the proportion of HLACTs that reported results within the 12-month interval mandated by the FDAAA or at any time during the 5-year study period. We used regression models to examine characteristics associated with reporting at 12 months and throughout the 5-year study period. RESULTS: From all the trials at ClinicalTrials.gov, we identified 13,327 HLACTs that were terminated or completed from January 1, 2008, through August 31, 2012. Of these trials, 77.4% were classified as drug trials. A total of 36.9% of the trials were phase 2 studies, and 23.4% were phase 3 studies; 65.6% were funded by industry. Only 13.4% of trials reported summary results within 12 months after trial completion, whereas 38.3% reported results at any time up to September 27, 2013. Timely reporting was independently associated with factors such as FDA oversight, a later trial phase, and industry funding. A sample review suggested that 45% of industry-funded trials were not required to report results, as compared with 6% of trials funded by the National Institutes of Health (NIH) and 9% of trials that were funded by other government or academic institutions. CONCLUSIONS: Despite ethical and legal obligations to disclose findings promptly, most HLACTs did not report results to ClinicalTrials.gov in a timely fashion during the study period. Industry-funded trials adhered to legal obligations more often than did trials funded by the NIH or other government or academic institutions. (Funded by the Clinical Trials Transformation Initiative and the NIH.).

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  • Data in study registries may not have been published in any other location.

    “This data may not have been published in any other location, making study registries a critical component of an information strategy, though timely reporting remains a challenge [58, 59].”

    From PRISMA-S: an extension to the PRISMA Statement for Reporting Literature Searches in Systematic Reviews (2021) · cites this paper as [58]

    The introductory passage (section labeled Abstract > Conclusions; page unavailable) discusses selective publication of trial results and describes ClinicalTrials.gov as a place for reporting results. That supports the possibility that registry results are not published elsewhere, but the paper does not establish whether the data in its registry sample were available in other locations. (LLM, conf=0.77)

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  • Study registries are a critical component of an information strategy.

    “This data may not have been published in any other location, making study registries a critical component of an information strategy, though timely reporting remains a challenge [58, 59].”

    From PRISMA-S: an extension to the PRISMA Statement for Reporting Literature Searches in Systematic Reviews (2021) · cites this paper as [58]

  • Timely reporting remains a challenge.

    “This data may not have been published in any other location, making study registries a critical component of an information strategy, though timely reporting remains a challenge [58, 59].”

    From PRISMA-S: an extension to the PRISMA Statement for Reporting Literature Searches in Systematic Reviews (2021) · cites this paper as [58]

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Authors
Anderson, M. L., Chiswell, K., Peterson, E. D., Tasneem, A., Topping, J., & Califf, R. M.
Affiliations
  • Duke University (US)
  • Duke Medical Center (US)
ORCID
Venue
New England Journal of Medicine
Publisher
Massachusetts Medical Society
Published
2015-03-12
Volume
372
Issue
11
Pages
1031-1039
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
DOI
10.1056/nejmsa1409364
PMC
PMC4508873
OpenAlex
W1963526469
Cited by
380
References
19
Citations by year
2026: 21 · 2025: 14 · 2024: 17 · 2023: 18 · 2022: 36 · 2021: 33 · 2020: 37 · 2019: 28 · 2018: 51 · 2017: 38 · 2016: 50 · 2015: 36 · 2014: 1
FWCI
68.45
Type
journal article
Language
en
Open access
Licence
public-domain
Locations
  • New England Journal of Medicine (publishedVersion, public-domain)
  • PubMed (publishedVersion)
  • Europe PMC (PubMed Central) (acceptedVersion)
  • PubMed Central (acceptedVersion)
  • DukeSpace (Duke University) (submittedVersion)
Funders
  • National Institutes of Health
  • U.S. National Library of Medicine
  • Duke Clinical Research Institute
  • National Center for Complementary and Integrative Health (U54AT007748)
Topics
  • Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmaceutical industry and healthcare
  • Social Sciences › Decision Sciences › Information Systems and Management › Academic Publishing and Open Access
  • Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
Keywords
ClinicalTrials.gov, result reporting, clinical trial transparency, regulatory compliance, industry-funded trials, trial phase, FDA oversight, drug trials
MeSH terms
Algorithms, Clinical Trials as Topic, Drug Industry, Humans, National Library of Medicine (U.S.), Registries, Research Support as Topic, United States, United States Food and Drug Administration, Proportional Hazards Models, Databases, Factual, Disclosure, Government Regulation, Mandatory Programs

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