Pragmatic Clinical Studies to Evaluate Patient-Centered Outcomes -- Cycle 1 2021

The Pragmatic Clinical Studies to Evaluate Patient-Centered Outcomes PFA emphasizes relevant Methodology Standards and the PCORI Guidance on the Design and Conduct of Trials in Real-World Settings.

PCORI seeks to fund clinical trials, large simple trials, or large-scale observational studies that compare two or more alternatives for addressing prevention, diagnosis, treatment, or management of a disease or symptom; improving healthcare system-level approaches to managing care; or eliminating health or healthcare disparities. Randomized study designs are strongly encouraged but not required.

Proposed studies must address critical clinical choices faced by patients, their caregivers, clinicians, or delivery systems. They must involve broadly representative patient populations and be large enough to provide precise estimates of hypothesized effectiveness differences and to support evaluation of potential differences in treatment effectiveness in patient subgroups.

Updated February 4, 2021

Please note: The PCORI Cost Principles state that PCORI will not cover costs for study interventions that constitute the procedures, treatments, interventions, or other standard clinical care (“patient care”) that is being proposed for comparison in the research project (“patient care costs”).

However, for this funding cycle of Pragmatic Clinical Studies, PCORI will pilot consideration of funding support for meritorious applications providing well-supported and justified requests to cover patient care costs defined to include the intervention being studied as well as clinical personnel costs for those providing the care. For additional information on the conditions for such coverage, see the Coverage of Intervention Costs section in the funding announcement. Applicants should submit a realistic budget and timeline reflecting the proposed study’s scope and requirements.