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Cited by 517Pharmaceutical industry and healthcareStatistical Methods in Clinical TrialsMeta-analysis and systematic reviews

The DOI matches its Crossref record; 28 of the 28 references it cites were found in a registry or an index.

Characteristics of Clinical Trials Registered in ClinicalTrials.gov, 2007-2010

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Califf, Robert M.·2012·JAMA
DOI 10.1001/jama.2012.3424PMC PMC13431740
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Abstract

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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Research works printed but not linked: 3

  1. [7]Uniform requirements for manuscripts submitted to biomedical journals: obligation to register clinical trials. International Committee of Medical Journal Editors. http://www.icmje.org/publishing_10register.html. Accessed January 3, 2012.
  2. [25]Kris MG, Meropol NJ, Winer EP, eds. Accelerating progress against cancer: ASCO’s blueprint for transforming clinical and translational cancer research. American Society of Clinical Oncology. http://www.asco.org/ascov2/department%20content/cancer%20policy%20and%20clinical%20affairs/downloads/blueprint.pdf. Accessed February 5, 2012. 22215747
  3. [36]English RA, Leibowitz Y, Giffin RB. Chapter 2: The state of clinical research in the United States: an overview. In: Transforming Clinical Research in the United States: Challenges and Opportunities: Workshop Summary. National Academies Press. http://books.nap.edu/openbook.php?record_id=12900. Accessed February 15, 2012.

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Metadata

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
DOI
10.1001/jama.2012.3424
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
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
  • Health Sciences › Nursing › Issues, ethics and legal aspects › 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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