The Patient-Centered Outcomes Research Institute (PCORI) intends to release a Phased Large Awards for Comparative Effectiveness Research (PLACER) PCORI Funding Announcement (PFA) on December 3, 2024, seeking to fund high-quality patient-centered comparative clinical effectiveness research (CER) projects that will address critical decisions faced by patients, families, caregivers and the broader health and healthcare community and for which there is insufficient evidence. This preannouncement provides potential applicants additional time to identify collaborators; obtain patient, community and partner input on potential studies; and create responsive, high-quality proposals.
Investigators must propose an individual-level or cluster-randomized controlled trial of significant scale and scope for this PFA. The proposed trial should address a critical decisional dilemma that requires 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 announcement anticipates that proposed research projects will require two phases of funding. The initial phase of funding supports a distinct feasibility phase intended for study refinement, infrastructure establishment, patient and stakeholder engagement and feasibility testing of study operations, including successfully recruiting, enrolling and randomizing participants. 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.
- Required Letter of Intent (LOI) Deadline
Jan. 14, 2025; 5 pm (ET) - LOI Status Notification
Feb. 11, 2025 - Application Deadline
May 6, 2025; 5 pm (ET)
Letter of Intent (LOI) Deadline: Oct. 1, 2024
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.