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Publication and reporting of clinical trial results: cross sectional analysis across academic medical centers
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OBJECTIVE: To determine rates of publication and reporting of results within two years for all completed clinical trials registered in ClinicalTrials.gov across leading academic medical centers in the United States. DESIGN: Cross sectional analysis. SETTING: Academic medical centers in the United States. PARTICIPANTS: Academic medical centers with 40 or more completed interventional trials registered on ClinicalTrials.gov. METHODS: Using the Aggregate Analysis of ClinicalTrials.gov database and manual review, we identified all interventional clinical trials registered on ClinicalTrials.gov with a primary completion date between October 2007 and September 2010 and with a lead investigator affiliated with an academic medical center. MAIN OUTCOME MEASURES: The proportion of trials that disseminated results, defined as publication or reporting of results on ClinicalTrials.gov, overall and within 24 months of study completion. RESULTS: We identified 4347 interventional clinical trials across 51 academic medical centers. Among the trials, 1005 (23%) enrolled more than 100 patients, 1216 (28%) were double blind, and 2169 (50%) were phase II through IV. Overall, academic medical centers disseminated results for 2892 (66%) trials, with 1560 (35.9%) achieving this within 24 months of study completion. The proportion of clinical trials with results disseminated within 24 months of study completion ranged from 16.2% (6/37) to 55.3% (57/103) across academic medical centers. The proportion of clinical trials published within 24 months of study completion ranged from 10.8% (4/37) to 40.3% (31/77) across academic medical centers, whereas results reporting on ClinicalTrials.gov ranged from 1.6% (2/122) to 40.7% (72/177). CONCLUSIONS: Despite the ethical mandate and expressed values and mission of academic institutions, there is poor performance and noticeable variation in the dissemination of clinical trial results across leading academic medical centers.
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“Meta-research studies have found that more than a quarter of unpublished trials in various countries had results available in trial registries, and some data (particularly harms) were more completely reported in registries than in journal publications.113 124 125 126 127”
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Metadata
- Authors
- Chen, R., Desai, N. R., Ross, J. S., Zhang, W., Chau, K. H., Wayda, B., Murugiah, K., Lu, D. Y., Mittal, A., & Krumholz, H. M.
- Affiliations
- University of California, San Francisco (US)
- Yale New Haven Hospital (US)
- Columbia University Irving Medical Center (US)
- Yale University (US)
- University of Pennsylvania Health System (US)
- Corresponding author
- Krumholz, Harlan M
- ORCID
- Venue
- BMJ
- Publisher
- BMJ
- Published
- 2016-02-17
- Volume
- 352
- Pages
- i637
- ISSN
- 1756-1833 (ISSN-L)
- PMC
- PMC4768882
- OpenAlex
- W2277874940
- Cited by
- 227
- References
- 22
- Citations by year
- 2026: 10 · 2025: 9 · 2024: 19 · 2023: 14 · 2022: 18 · 2021: 31 · 2020: 21 · 2019: 21 · 2018: 35 · 2017: 24 · 2016: 25
- FWCI
- 43.75
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- BMJ (publishedVersion, cc-by-nc)
- Europe PMC (PubMed Central) (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- HighWire Press Open Archive (submittedVersion)
- Funders
- American Federation for Aging Research (K08AG032886)
- Yale University
- Agency for Healthcare Research and Quality (K12HS023000, K12 HS023000-01)
- National Institute on Aging (K08AG032886)
- National Heart, Lung, and Blood Institute (U01HL105270)
- 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
- publication rates, ClinicalTrials.gov, academic medical centers, clinical trial registration, result reporting, time to publication
- MeSH terms
- Academic Medical Centers, Clinical Trials as Topic, Cross-Sectional Studies, Humans, Publishing, United States, Databases, Factual
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