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
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.
Overview
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Integrity signals
Registry
Cites
Statistics
Verification
Claims the paper makes
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
In the citing paper
“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]
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
The self-check needs the paper’s full text.
Citations
Cites
GRADE: an emerging consensus on rating quality of evidence and strength of recommendations
Guyatt, G. H., Oxman, A. D., Vist, G. E., Kunz, R., Falck-Ytter, Y., Alonso-Coello, P., & Schünemann, H. J. (2008) · BMJ · doi:10.1136/bmj.39489.470347.ad · Cited by 23,305
Moher, D., Schulz, K. F., & Altman, D. G. (2001) · The Lancet · doi:10.1016/s0140-6736(00)04337-3 · Cited by 5,373
Moher, D. (2001) · JAMA · doi:10.1001/jama.285.15.1987 · Cited by 2,545
Clinical Trial Registration: A Statement from the International Committee of Medical Journal Editors
De Angelis, C., Drazen, J. M., Frizelle, F. A., Haug, C., Hoey, J., Horton, R., Kotzin, S., Laine, C., Marusic, A., Overbeke, A. J. P. M., et al. (2004) · New England Journal of Medicine · doi:10.1056/nejme048225 · Cited by 1,241
Central challenges facing the national clinical research enterprise
Sung, N. S., Crowley, W. F., Genel, M., Salber, P., Sandy, L., Sherwood, L. M., Johnson, S. B., Catanese, V., Tilson, H., Getz, K., et al. (2003) · JAMA · doi:10.1001/jama.289.10.1278 · Cited by 1,235
Scientific evidence underlying the ACC/AHA clinical practice guidelines.
Tricoci, P. (2009) · JAMA · doi:10.1001/jama.2009.205 · Cited by 908
The ClinicalTrials.gov Results Database — Update and Key Issues
Zarin, D. A., Tse, T., Williams, R. J., Califf, R. M., & Ide, N. C. (2011) · New England Journal of Medicine · doi:10.1056/nejmsa1012065 · Cited by 838
Self-citationEthical and Scientific Implications of the Globalization of Clinical Research
Glickman, S. W., McHutchison, J. G., Peterson, E. D., Cairns, C. B., Harrington, R. A., Califf, R. M., & Schulman, K. A. (2009) · New England Journal of Medicine · doi:10.1056/nejmsb0803929 · Cited by 710
Self-citationWhy do we need some large, simple randomized trials?
Yusuf, S., Collins, R., & Peto, R. (1984) · Statistics in Medicine · doi:10.1002/sim.4780030421 · Cited by 700
DeAngelis, C. D., Drazen, J. M., Frizelle, F., Haug, C. J., Hoey, J., Horton, R. C., Kotzin, S., Laine, C. M., Marušić, A., Overbeke, A. J. P. M., et al. (2004) · JAMA · doi:10.1001/jama.292.11.1363 · Cited by 579
Flagged first, then by citations
Research works printed but not linked: 3
- [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.
- [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
- [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.
Cited by
Sorted by citations
SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials
Chan, A.-W., Tetzlaff, J. M., Gotzsche, P. C., Altman, D. G., Mann, H., Berlin, J. A., Dickersin, K., Hrobjartsson, A., Schulz, K. F., Parulekar, W. R., et al. (2013) · BMJ · doi:10.1136/bmj.e7586 · Cited by 6,251
Industry sponsorship and research outcome
Lundh, A., Lexchin, J., Mintzes, B., Schroll, J. B., & Bero, L. (2017) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.mr000033.pub3 · Cited by 1,697
Paediatric cancer in low-income and middle-income countries
Magrath, I., Steliarova-Foucher, E., Epelman, S., Ribeiro, R. C., Harif, M., Li, C.-K., Kebudi, R., Macfarlane, S. D., & Howard, S. C. (2013) · The Lancet Oncology · doi:10.1016/s1470-2045(13)70008-1 · Cited by 422
Compliance with Results Reporting at ClinicalTrials.gov
Anderson, M. L., Chiswell, K., Peterson, E. D., Tasneem, A., Topping, J., & Califf, R. M. (2015) · New England Journal of Medicine · doi:10.1056/nejmsa1409364 · Cited by 380
Self-citationNon-publication of large randomized clinical trials: cross sectional analysis
Jones, C. W., Handler, L., Crowell, K. E., Keil, L. G., Weaver, M. A., & Platts-Mills, T. F. (2013) · BMJ · doi:10.1136/bmj.f6104 · Cited by 350
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
- 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
- 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
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
