Characteristics of Clinical Trials Registered in ClinicalTrials.gov, 2007-2010
Open accessAbstract
CONTEXT: Recent reports highlight gaps between guidelines-based treatment recommendations and evidence from clinical trials that supports those recommendations. Strengthened reporting requirements for studies registered with ClinicalTrials.gov enable a comprehensive evaluation of the national trials portfolio. OBJECTIVE: To examine fundamental characteristics of interventional clinical trials registered in the ClinicalTrials.gov database. METHODS: A data set comprising 96,346 clinical studies from ClinicalTrials.gov was downloaded on September 27, 2010, and entered into a relational database to analyze aggregate data. Interventional trials were identified and analyses were focused on 3 clinical specialties-cardiovascular, mental health, and oncology-that together encompass the largest number of disability-adjusted life-years lost in the United States. MAIN OUTCOME MEASURES: Characteristics of registered clinical trials as reported data elements in the trial registry; how those characteristics have changed over time; differences in characteristics as a function of clinical specialty; and factors associated with use of randomization, blinding, and data monitoring committees (DMCs). RESULTS: The number of registered interventional clinical trials increased from 28,881 (October 2004-September 2007) to 40,970 (October 2007-September 2010), and the number of missing data elements has generally declined. Most interventional trials registered between 2007 and 2010 were small, with 62% enrolling 100 or fewer participants. Many clinical trials were single-center (66%; 24,788/37,520) and funded by organizations other than industry or the National Institutes of Health (NIH) (47%; 17,592/37,520). Heterogeneity in the reported methods by clinical specialty; sponsor type; and the reported use of DMCs, randomization, and blinding was evident. For example, reported use of DMCs was less common in industry-sponsored vs NIH-sponsored trials (adjusted odds ratio [OR], 0.11; 95% CI, 0.09-0.14), earlier-phase vs phase 3 trials (adjusted OR, 0.83; 95% CI, 0.76-0.91), and mental health trials vs those in the other 2 specialties. In similar comparisons, randomization and blinding were less frequently reported in earlier-phase, oncology, and device trials. CONCLUSION: Clinical trials registered in ClinicalTrials.gov are dominated by small trials and contain significant heterogeneity in methodological approaches, including reported use of randomization, blinding, and DMCs.
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The use of a data monitoring committee was reported for 29% of trial protocols approved from 2000 to 2003 in Switzerland, Germany, and Canada, and for about 40% of trials registered on ClinicalTrials.gov from 2007 to 2010.
“The use of a data monitoring committee was reported for 29% of trial protocols approved from 2000 to 2003 in Switzerland, Germany, and Canada,453 454 and for about 40% of trials registered on ClinicalTrials.gov from 2007 to 2010.”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [453]
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Time to improve the reporting of harms in randomized controlled trials
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Global migration of clinical research during the era of trial registration
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Are current clinical trials in diabetes addressing important issues in diabetes care?
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Failed Randomized Clinical Trials in Radiation Oncology: What Can We Learn?
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Global migration of clinical trials
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Genetic factors associated with reasons for clinical trial stoppage
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Use of data from registered clinical trials to identify gaps in health research and development
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Targeted Therapies in Neuroendocrine Tumors (NET): Clinical Trial Challenges and Lessons Learned
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Clinical Trials in Peripheral Vascular Disease
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Adaptive pre‐specification in randomized trials with and without pair‐matching
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In search of evidence-based treatment for concussion: characteristics of current clinical trials
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Evaluating the Completeness of ClinicalTrials.gov
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The COVID-19 pandemic and new clinical trial activations
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Open Access to Clinical Trials Data
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The landscape of precision cancer medicine clinical trials in the United States
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Some data quality issues at ClinicalTrials.gov
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Pragmatic Trials in Maintenance Dialysis: Perspectives from the Kidney Health Initiative
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- Authors
- Califf, R. M.
- Affiliations
- Duke University (US)
- Corresponding author
- Califf, Robert M.
- ORCID
- Califf, Robert M.
- Venue
- JAMA
- Publisher
- American Medical Association (AMA)
- Published
- 2012-05-02
- Volume
- 307
- Issue
- 17
- Pages
- 1838
- ISSN
- 0002-9955 (ISSN-L)
- 0098-7484
- PMC
- PMC13431740
- OpenAlex
- W2017857169
- Cited by
- 516
- References
- 28
- Citations by year
- 2026: 14 · 2025: 26 · 2024: 39 · 2023: 36 · 2022: 34 · 2021: 39 · 2020: 37 · 2019: 28 · 2018: 39 · 2017: 35 · 2016: 38 · 2015: 37 · 2014: 42 · 2013: 52 · 2012: 17
- FWCI
- 53.67
- Type
- journal article
- Language
- en
- Open access
- green
- pmc.ncbi.nlm.nih.gov
- Locations
- JAMA (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (publishedVersion)
- University Libraries (University of Maryland) (submittedVersion)
- Radboud Repository (Radboud University) (submittedVersion)
- Digital Repository at the University of Maryland (University of Maryland College Park)
- Funders
- U.S. Food and Drug Administration (U19FD003800)
- Topics
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmaceutical industry and healthcare
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Keywords
- ClinicalTrials.gov, randomization, blinding, data monitoring committees, trial funding, industry-sponsored trials, trial phase, cardiovascular clinical trials, cancer clinical trials, evidence-based medicine, single-center trials
- MeSH terms
- Mental Disorders, Cardiovascular Diseases, Clinical Trials as Topic, Drug Industry, Humans, National Institutes of Health (U.S.), Neoplasms, Registries, Research Design, Research Support as Topic, United States, Randomized Controlled Trials as Topic, Databases, Factual, Sample Size
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