Funder: Patient-Centered Outcomes Research Institute (PCORI)
Due Dates: May 13, 2025 (LOI) | September 3, 2025 (Full Application, by invitation)
Funding Amounts: Up to $22 million direct costs per project (Feasibility phase: $2M, up to 18 months; Full-scale phase: $20M, up to 5 years; total project period up to 6.5 years)
Summary: Supports large, high-impact randomized controlled trials in patient-centered comparative effectiveness research, with a required feasibility phase and strong stakeholder engagement.
Key Information: Requires dual leadership (Clinical and Data Coordinating Centers); only one large RCT per award; minimum direct cost request is $12M; patient care costs may be requested with strong justification.
Description
This opportunity from PCORI funds large-scale, high-impact randomized controlled trials (RCTs) in patient-centered comparative clinical effectiveness research (CER). Projects must address critical healthcare decisions faced by patients, caregivers, clinicians, and the broader health community, where current evidence is insufficient. The program is structured in two phases: an initial feasibility phase (up to 18 months) to refine study design, test recruitment and randomization, and establish infrastructure and engagement, followed by a full-scale trial phase (up to 5 years) contingent on successful completion of feasibility milestones.
Studies must compare interventions with robust evidence of efficacy and current use (or, if efficacy is not well established, document widespread use). Both clinical and delivery system interventions are eligible. Meaningful patient and stakeholder engagement is required throughout, and applications must demonstrate shared trial leadership between a Clinical Coordinating Center (CCC) and a Data Coordinating Center (DCC).
Due Dates
- PCORI Online Opens: April 1, 2025
- Applicant Town Hall: April 4, 2025
- Letter of Intent (LOI) Deadline: May 13, 2025, 5 pm ET
- LOI Status Notification: June 10, 2025
- Application Deadline (by invitation): September 3, 2025, 5 pm ET
- Merit Review: November 2025
- Awards Announced: March 2026
- Earliest Project Start Date: July 2026
Funding Amount
- Total Direct Costs: Up to $22 million per project
- Feasibility Phase: Up to $2 million (up to 18 months)
- Full-Scale Study Phase: Up to $20 million (up to 5 years)
- Minimum Direct Cost Request: $12 million (applications below this are nonresponsive)
- Total Project Period: Up to 6.5 years (does not include peer review period)
- Total Funds Available: Up to $120 million for this cycle
Eligibility
- Eligible Applicants:
- Academic institutions
- Non-profit and for-profit research organizations
- Government agencies
- Small businesses
- Other organizations capable of conducting large-scale research
- Ineligible: Individuals may not apply.
- International Applicants: Must justify benefit to the U.S. healthcare system and include U.S. patients/stakeholders.
- Project Structure: Only one large RCT per award (no program/center grants or multiple RCTs).
- Dual Leadership Required: Strongly encouraged to have dual PIs—one from the CCC and one from the DCC.
Application Process
- Register in PCORI Online: The Contact PI must register and initiate the application.
- Submit Letter of Intent (LOI): Required for all applicants; use the LOI template.
- LOI Review: Only selected applicants will be invited to submit a full application.
- Full Application (by invitation): Must follow detailed submission instructions and use required templates.
- Milestones: Propose specific, measurable milestones for the feasibility phase; continuation to full-scale phase is contingent on their achievement.
- Budget: Use the Detailed Budget Template and Budget Justification Template.
- Engagement Plan: Address PCORI’s Foundational Expectations for Partnerships in Research.
- Deferral Policy: Invited applicants may defer submission once to the next cycle (request at least 4 weeks before the application deadline).
Eligibility
- Applicants: Academic, non-profit, for-profit, government, and other research organizations.
- Individuals: Not eligible.
- International/Foreign Organizations: Must justify U.S. relevance and engagement.
- Project Requirements:
- Must propose a single, large RCT (individual or cluster randomization).
- Must include both a Clinical Coordinating Center (CCC) and a Data Coordinating Center (DCC) with independent leadership.
- Must address at least one of three PCORI National Priorities for Health:
- Strengthening/expanding CER on existing interventions/emerging innovations
- Fostering improvements in patient-centered experiences, care, and outcomes
- Expanding stakeholder engagement, research, and dissemination to improve outcomes for all
Additional Information
- Patient Care Costs: May be requested with strong justification; applicants are encouraged to seek outside cost-sharing and must detail requests in the LOI and application.
- Stakeholder Engagement: Must be meaningful, ongoing, and budgeted; engagement leadership is required.
- Nonresponsive Applications: Observational studies, quality improvement projects, development of new interventions, or studies lacking robust evidence of intervention efficacy/use are not eligible.
- Data Sharing: Awardees must comply with PCORI’s Policy for Data Management and Data Sharing.
- Peer Review: All funded projects undergo PCORI peer review; budget for peer review costs is required.
- Resources: Extensive templates and guidance are available on the PCORI PLACER PFA page.
External Links
Contact Information