A national strategy to develop pragmatic clinical trials infrastructure
Open accessAbstract
An important challenge in comparative effectiveness research is the lack of infrastructure to support pragmatic clinical trials, which compare interventions in usual practice settings and subjects. These trials present challenges that differ from those of classical efficacy trials, which are conducted under ideal circumstances, in patients selected for their suitability, and with highly controlled protocols. In 2012, we launched a 1‐year learning network to identify high‐priority pragmatic clinical trials and to deploy research infrastructure through the NIH Clinical and Translational Science Awards Consortium that could be used to launch and sustain them. The network and infrastructure were initiated as a learning ground and shared resource for investigators and communities interested in developing pragmatic clinical trials. We followed a three‐stage process of developing the network, prioritizing proposed trials, and implementing learning exercises that culminated in a 1‐day network meeting at the end of the year. The year‐long project resulted in five recommendations related to developing the network, enhancing community engagement, addressing regulatory challenges, advancing information technology, and developing research methods. The recommendations can be implemented within 24 months and are designed to lead toward a sustained national infrastructure for pragmatic trials.
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Practice-based research networks strive to generate results that are relevant to both patients and clinicians, by comparing interventions among participants and representative settings of usual care.
“These networks strive to generate results that are relevant to both patients and clinicians, by comparing interventions among participants and representative settings of usual care [2].”
From Dental Practice-Based Research Networks (D-PBRN) worldwide: a scoping review. (2021) · cites this paper as [2]
The Background says pragmatic clinical trials strive to produce results relevant to patients and clinicians by comparing interventions in participants and settings representative of usual care. It lists practice-based research networks as supporting such trials, but does not specifically attribute that aim or comparison method to the networks themselves. No page number is available in our copy. (LLM, conf=0.88)
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Self-citation
- Authors
- Concannon, T. W., Guise, J., Dolor, R. J., Meissner, P., Tunis, S., Krishnan, J. A., Pace, W. D., Saltz, J., Hersh, W. R., Michener, L., & Carey, T. S.
- Affiliations
- Tufts University (US)
- Oregon Health & Science University (US)
- Duke University (US)
- Albert Einstein College of Medicine (US)
- Center for Medical Technology Policy (US)
- University of Illinois Chicago (US)
- University of Colorado Denver (US)
- Emory University (US)
- University of North Carolina at Chapel Hill (US)
- Corresponding author
- Concannon, Thomas W.
- ORCID
- Venue
- Clinical and Translational Science
- Publisher
- Wiley
- Published
- 2014-01-28
- Volume
- 7
- Issue
- 2
- Pages
- 164-171
- ISSN
- 1752-8054 (ISSN-L)
- 1752-8062
- PMC
- PMC4126802
- OpenAlex
- W2137351884
- Semantic Scholar
- 857f8b4b165d10fab719893a17c5d2e29a895fda
- Cited by
- 31
- References
- 25
- Citations by year
- 2026: 1 · 2025: 3 · 2024: 2 · 2023: 3 · 2022: 2 · 2020: 4 · 2019: 6 · 2018: 1 · 2017: 4 · 2016: 1 · 2015: 3 · 2014: 1
- FWCI
- 5.42
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Clinical and Translational Science (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Funders
- National Center for Advancing Translational Sciences
- National Heart, Lung & Blood Institute
- National Institutes of Health (UL1 TR000073, UL1 TR001064)
- Topics
- Health Sciences › Health Professions › General Health Professions › Health Policy Implementation Science
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Health and Medical Research Impacts
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Keywords
- pragmatic trials, research infrastructure, comparative effectiveness research, learning networks, community participation, regulatory challenges, national strategy
- MeSH terms
- Health Planning Guidelines, Humans, United States, Program Development, Translational Research, Biomedical, Pragmatic Clinical Trials as Topic
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