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Publication and reporting of clinical trial results: cross sectional analysis across academic medical centers

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Chen, Ruijun, Desai, Nihar R, Ross, Joseph S, Zhang, Weiwei, Chau, Katherine H, Wayda, Brian, Murugiah, Karthik, Lu, Daniel Y, Mittal, Amit, Krumholz, Harlan M·2016·BMJ

DOI 10.1136/bmj.i637PMC PMC4768882

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Abstract

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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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: Chen, Ruijun
Desai, Nihar R
Ross, Joseph S
Zhang, Weiwei
Chau, Katherine H
Wayda, Brian
Murugiah, Karthik
Lu, Daniel Y
Mittal, Amit
Krumholz, Harlan M
Venue: BMJ
Publisher: BMJ
Published: 2016-02-17
Volume: 352
Pages: i637
ISSN: 1756-1833 (ISSN-L)
DOI: 10.1136/bmj.i637
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: cc-by-nc
www.bmj.org/licenses/tdm/1.0/terms-and-conditions.html (tdm)
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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Publication and reporting of clinical trial results: cross sectional analysis across academic medical centers

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