The ClinicalTrials.gov Results Database — Update and Key Issues
Open accessAbstract
BACKGROUND: The ClinicalTrials.gov trial registry was expanded in 2008 to include a database for reporting summary results. We summarize the structure and contents of the results database, provide an update of relevant policies, and show how the data can be used to gain insight into the state of clinical research. METHODS: We analyzed ClinicalTrials.gov data that were publicly available between September 2009 and September 2010. RESULTS: As of September 27, 2010, ClinicalTrials.gov received approximately 330 new and 2000 revised registrations each week, along with 30 new and 80 revised results submissions. We characterized the 79,413 registry and 2178 results of trial records available as of September 2010. From a sample cohort of results records, 78 of 150 (52%) had associated publications within 2 years after posting. Of results records available publicly, 20% reported more than two primary outcome measures and 5% reported more than five. Of a sample of 100 registry record outcome measures, 61% lacked specificity in describing the metric used in the planned analysis. In a sample of 700 results records, the mean number of different analysis populations per study group was 2.5 (median, 1; range, 1 to 25). Of these trials, 24% reported results for 90% or less of their participants. CONCLUSIONS: ClinicalTrials.gov provides access to study results not otherwise available to the public. Although the database allows examination of various aspects of ongoing and completed clinical trials, its ultimate usefulness depends on the research community to submit accurate, informative data.
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ClinicalTrials.gov is the largest register and comprises most oral health trial protocols (71%).
“We searched ClinicalTrials.gov because it is the largest register and comprises most oral health trial protocols (71%) (Zarin et al. 2011; Smaïl-Faugeron et al. 2015).”
From Nonpublication and Selective Outcome Reporting of Oral Health Trials (2023) · cites this paper as Zarin et al. 2011
The Description of ClinicalTrials.gov identifies it as a registry of trial protocols, and the paper reports 79,413 registry records as of September 2010. It does not establish that it was the largest registry or report that it contained 71% of oral-health trial protocols (searched: largest, oral health, dental, 71%). (LLM, conf=0.82)
Experimental — accuracy not yet measuredUp to 38% of trials defined multiple primary outcomes.
“Although up to 38% of trials defined multiple primary outcomes,249 250 251 252”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [251]
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- Authors
- Zarin, D. A., Tse, T., Williams, R. J., Califf, R. M., & Ide, N. C.
- Affiliations
- National Institutes of Health (US)
- Duke University (US)
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2011-03-03
- Volume
- 364
- Issue
- 9
- Pages
- 852-860
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- PMC
- PMC3066456
- OpenAlex
- W1993595811
- Cited by
- 838
- References
- 24
- Citations by year
- 2026: 70 · 2025: 45 · 2024: 44 · 2023: 57 · 2022: 74 · 2021: 70 · 2020: 57 · 2019: 46 · 2018: 52 · 2017: 58 · 2016: 35 · 2015: 47 · 2014: 51 · 2013: 59 · 2012: 51
- FWCI
- 164.32
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Institutes of Health (Z99 LM999999)
- U.S. National Library of Medicine (ZIALM008926)
- Topics
- Physical Sciences › Computer Science › Information Systems › Research Data Management Practices
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmaceutical industry and healthcare
- Keywords
- ClinicalTrials.gov, clinical trial registries, clinical trial registration, time to publication, outcome measures, data quality
- MeSH terms
- Clinical Trials as Topic, National Library of Medicine (U.S.), Public Policy, Quality Control, Registries, United States, United States Food and Drug Administration, Databases, Factual, Outcome Assessment, Health Care, Government Regulation, Information Dissemination
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