An official website of the United States governmentConcept: Pragmatic and Implementation Trials Conducted in Real-World Settings Delivering Health Care
Project Concept Review
Council Approval: April 17, 2026
Program Directors: Beda Jean-Francois, Ph.D.
Background
While many biomedical and behavioral interventions have demonstrated efficacy under controlled research conditions, less is known about how these interventions perform when embedded in real-world settings delivering health care (e.g., public health departments, primary clinics, specialty care facilities, long-term care facilities, community hospitals, school-based clinics). Variability in patient populations, clinical workflows, staffing, resources, and local context can influence both effectiveness and implementation, yet these factors are often insufficiently studied prior to widespread dissemination.
Pragmatic clinical trials (PCTs) and implementation trials provide rigorous approaches to evaluate the effectiveness of interventions, clinical guidelines, technologies, and policies as they are routinely delivered in real-world settings, thereby enhancing external validity and informing ongoing improvement in practice. These settings need research to inform the care they deliver. Results from pragmatic and implementation trials can inform decision making across multiple levels of public health and health care systems, including patients, providers, administrators, payers, and policymakers, about the comparative benefits, burdens, and risks of biomedical or behavioral interventions.
Partnerships with public health and health care systems are critical for the conduct of PCTs and implementation trials. Engagement with these settings can strengthen the impact of clinical findings and accelerate the translation of research evidence into practice. In addition, advances in artificial intelligence (AI) and informatics have expanded opportunities to conduct PCT and implementation research within these real-world settings. Effective use of existing health system infrastructure, however, requires careful consideration of ethical and regulatory issues, as well as rigorous study design and analytic methods.
Purpose of Proposed Initiative
The purpose of the proposed initiative is to support large-scale embedded pragmatic trials that test intervention effectiveness in routine care and/or implementation trials that evaluate strategies for delivering interventions within real-world health care settings to improve health outcomes for populations in a variety of contexts. This initiative aligns well with the National Institutes of Health priority of supporting replication and reproducibility in biomedical science by determining if biomedical or behavioral interventions remain effective when integrated in real-world settings. Strengthening both the internal and external validity of evidence-based interventions across a range of health care delivery settings has the potential to improve care for all populations.
Objectives
The objectives to be met by the initiative include, but are not limited to, the following:
- Support pragmatic trials that assess the effectiveness of evidence-based clinical, behavioral, preventive, or system-level interventions in real-world settings delivering health care
- Support implementation studies to identify evidence-based strategies that promote successful adoption, adaptation, integration, and sustainability of evidenced-based interventions in real-world settings delivering health care