Prevalence, characteristics, and predictors of early termination of cardiovascular clinical trials due to low recruitment: Insights from the ClinicalTrials.gov registry
Abstract
Background Early termination of clinical trials due to low recruitment represents an understudied challenge for clinical research. We aimed to describe characteristics of cardiovascular trials terminated because of low recruitment and identify the major predictors of such early termination.Methods We reviewed all cardiovascular clinical trials (7,042 studies) registered in ClinicalTrials.gov from February 29, 2000, to January 17, 2013, and assessed information about trials that were completed and those that were terminated early. Logistic regression models were developed to identify independent predictors of early termination due to low recruitment.Results Our search strategy identified 6,279 cardiovascular clinical trials, of which 684 (10.9%) were terminated prematurely. Of these halted trials, the main reason for termination was lower than expected recruitment (278 trials; 53.6%). When comparing trials that terminated early because of low recruitment with those that were completed, we found that studies funded by the National Institutes of Health or other US federal agencies (odds ratio [OR] 0.35, 95% confidence interval [CI] 0.14-0.89), studies of behavior/diet intervention (OR 0.35, 95% CI 0.19-0.65), and single-arm design studies (OR 0.57, 95% CI 0.42-0.78) were associated with a lower risk of early termination. University/hospital-funded (OR 1.52, 95% CI 1.10-2.10) and mixed-source-funded studies (OR 2.14, 95% CI 1.52-3.01) were associated with a higher likelihood of early termination due to lower than expected recruitment rates.Conclusions Low recruitment represents the main cause of early termination of cardiovascular clinical trials. Funding source, type of intervention, and study design are factors associated with early termination due to low recruitment and might be good targets for improving enrollment into cardiovascular clinical trials.
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International trials of various pharmacotherapies have sometimes found discordant results in patients enrolled in the United States than seen in overall trial results.
“International trials of various pharmacotherapies have sometimes found discordant results in patients enrolled in the United States than seen in overall trial results.19–32”
From REDUCE-IT USA: Results From the 3146 Patients Randomized in the United States (2020) · cites this paper as [25]
The reasons for discordant US results range from low numbers of patients enrolled in the United States to potential differences in background medical management or in patient risk profiles.
“The reasons range from low numbers of patients enrolled in the United States to potential differences in background medical management or in patient risk profiles.”
From REDUCE-IT USA: Results From the 3146 Patients Randomized in the United States (2020) · cites this paper as [25]
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- Authors
- Bernardez-Pereira, S., Lopes, R. D., Carrion, M. J. M., Santucci, E. V., Soares, R. M., de Oliveira Abreu, M., Laranjeira, L. N., Ikeoka, D. T., Zazula, A. D., Moreira, F. R., Cavalcanti, A. B., Mesquita, E. T., Peterson, E. D., Califf, R. M., & Berwanger, O.
- Affiliations
- Hospital do Coração (BR)
- Universidade Federal Fluminense (BR)
- Duke Medical Center (US)
- Corresponding author
- Berwanger, Otavio
- ORCID
- Venue
- American Heart Journal
- Publisher
- Elsevier BV
- Published
- 2014-08
- Volume
- 168
- Issue
- 2
- Pages
- 213-219.e1
- ISSN
- 0002-8703 (ISSN-L)
- OpenAlex
- W2077443075
- Cited by
- 94
- References
- 20
- Citations by year
- 2026: 7 · 2025: 4 · 2024: 6 · 2023: 10 · 2022: 16 · 2021: 10 · 2020: 12 · 2019: 4 · 2018: 4 · 2017: 6 · 2016: 10 · 2015: 4 · 2014: 1
- FWCI
- 6.94
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- American Heart Journal (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Health and Medical Research Impacts
- Keywords
- early trial termination, cardiovascular clinical trials, funding sources, clinical trial recruitment
- MeSH terms
- Adult, Cardiovascular Diseases, Clinical Trials as Topic, Female, Humans, Male, Middle Aged, National Library of Medicine (U.S.), Registries, United States, Selection Bias, Prevalence, Logistic Models, Patient Selection, Early Termination of Clinical Trials
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