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Compliance with Results Reporting at ClinicalTrials.gov
Open accessAbstract
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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“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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“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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“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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The ClinicalTrials.gov Results Database — Update and Key Issues
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Self-citationCharacteristics of Clinical Trials Registered in ClinicalTrials.gov, 2007-2010
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Self-citationClinical Trial Registration — Looking Back and Moving Ahead
Laine, C. M., Horton, R. C., DeAngelis, C. D., Drazen, J. M., Frizelle, F., Godlee, F., Haug, C. J., Hébert, P. C., Kotzin, S., Marušić, A., et al. (2007) · New England Journal of Medicine · doi:10.1056/nejme078110 · Cited by 320
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Disclosing Individual Results of Clinical Research: Implications of Respect for Participants
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Self-citationLaine, C. M., Horton, R. C., DeAngelis, C. D., Drazen, J. M., Frizelle, F., Godlee, F., Haug, C. J., Hébert, P. C., Kotzin, S., Marušić, A., et al. (2007) · JAMA · doi:10.1001/jama.298.1.jed70037 · Cited by 135
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Metadata
- Authors
- Anderson, M. L., Chiswell, K., Peterson, E. D., Tasneem, A., Topping, J., & Califf, R. M.
- Affiliations
- Duke University (US)
- Duke Medical Center (US)
- 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
- 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
- FWCI
- 68.45
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- 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
- Health Sciences › Nursing › Issues, ethics and legal aspects › Pharmaceutical industry and healthcare
- Social Sciences › Library and Information Sciences › 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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