This PCORI Funding Announcement (PFA) invites applications for high-quality patient-centered comparative clinical effectiveness research (CER) projects that will address critical decisions faced by patients, families, caregivers, clinicians, and the health and healthcare community and for which there is insufficient evidence.
Investigators must propose an individual-level or cluster randomized controlled trial of significant scale and scope for this PFA. The proposed trials should address critical decisional dilemmas that require important new evidence about the comparative clinical effectiveness of available interventions. Proposed studies should compare interventions that already have robust evidence of efficacy and are in current use. If efficacy is not well established, then widespread use must be documented. Clinical interventions (such as medications, diagnostic tests, or procedures) and delivery system interventions (such as workforce, technologies and healthcare service delivery designs) are appropriate for these studies.
This funding opportunity anticipates that proposed research projects will require two phases of funding. The initial phase of funding supports a distinct feasibility phase intended for purposes of study refinement, infrastructure establishment, patient and stakeholder engagement, and feasibility testing of study operations, including the ability to recruit, enroll, and randomize participants successfully. Using the feasibility phase to establish evidence of an intervention’s efficacy or effect size is not permitted. Approval to proceed to the second phase will be contingent on achieving specific milestones and deliverables established for the feasibility phase.
- Letter of Intent (LOI) Deadline
May 13, 2025; 5 pm (ET) - LOI Status Notification
June 10, 2025 - Application Deadline
Sept. 3, 2025
PCORI’s Research Project Agenda includes a set of Topic Themes that inform focused funding opportunities for patient-centered CER. The Topic Themes speak to health issues facing large numbers of people in the United States including children, youth and older adults and address urgent topics such as substance use, mental and behavioral health and violence and trauma, as well as widespread conditions including cardiovascular disease, pain management and sleep health.
Applicants to the Cycle 1 2025 PLACER PFA may select up to three Topic Themes within the Research Project Agenda that best align with their proposed research. Applicants may also opt not to select from the PCORI Topic Themes and select “other” to indicate that their research aligns with other areas of need for patient-centered CER. The National Priorities for Health and Topic Themes will assist PCORI in determining the optimal review pathway for the proposed research.
Investigators may request up to $2 million in direct costs for a feasibility phase up to 18 months in duration, with up to $20 million in direct costs for continuation to a full-scale study phase up to five years in duration. Total direct costs for the full proposal should not exceed $22 million.