Key Dates

  • LOI Status Notification:
    March 5, 2024
  • Application Deadline:
    May 7, 2024; 5 pm (ET)
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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 and enroll 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.

This funding opportunity seeks applications addressing any of the three National Priorities for Health listed below. To be considered responsive, applications must propose research meeting the distinctive requirements of this PFA and address at least one of the following National Priorities for Health:

  • Increase Evidence for Existing Interventions and Emerging Innovations in Health
    • Goal: Strengthen and expand ongoing comparative clinical effectiveness research focused on both existing interventions and emerging innovations to improve healthcare practice, health outcomes and health equity.
  • Achieve Health Equity
    • Goal: Expand stakeholder engagement, research and dissemination approaches that lead to continued progress toward achieving health equity in the United States.
  • Accelerate Progress Toward an Integrated Learning Health System
    • Goal: Foster actionable, timely, place-based and transformative improvements in patient-centered experiences, care provision and ultimately improved health outcomes through collaborative, multisectoral research to support a health system that understands and serves the needs and preferences of individuals.

Applicants will be asked to select one of the three National Priorities for Health above as primary, and if relevant, a secondary and/or tertiary National Priority for Health in their Letter of Intent (LOI) and, if invited, full application.

PCORI’s Topic Themes are also included in this funding opportunity. Applicants have the option to choose up to three Topic Themes, based on how their proposed research aligns with the themes. However, aligning with a Topic Theme is not required. The National Priorities for Health and Topic Themes will assist PCORI in determining the optimal review pathway for the proposed research. The National Priorities for Health and topic themes will assist PCORI in determining the optimal review pathway for the proposed research.

Meaningful patient and stakeholder engagement is viewed as an essential component of funded PLACER studies. During the feasibility phase, PCORI expects study teams to undertake engagement activities in support of study design, acceptability to participants, conduct, analysis, and dissemination of findings. Applicants should use multiple approaches that occur along a continuum of engagement from input to shared leadership.

Considering the scale, complexity and scope of trials being solicited under this PFA, PCORI requires that applications include shared trial leadership by a data coordinating center to provide an independent role in study leadership, advising on the analytical, statistical and data management aspects of both study phases. PCORI also requires that applications include experienced engagement leadership with demonstrated experience in patient and stakeholder engagement in large research studies or projects. 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.

This funding opportunity will be reposted for Cycle 2 2024.

Download Full Announcement

Key Dates

Online System Opens
January 9, 2024
Applicant Town Hall
-
View Event
Letter of Intent Deadline
February 6, 2024, by 5 pm (ET)
Letter of Intent Status Notification
March 5, 2024
Application Deadline
May 7, 2024, by 5 pm (ET)
Merit Review
July 2024
Awards Announced
November 2024
Earliest Start Date
April 2025

Funds and Project Period

Funds Available Up To
$200 million
Total Direct Costs
$22 million (Feasibility phase: $2 million; Full-scale study phase: $20 million)
Maximum Project Period
6.5 years (Feasibility phase: 1.5 years; Full-scale study phase: 5 years)

To Apply for This Opportunity

  1. Read the full funding announcement
  2. Follow the process outlined in the Submission Instructions
  3. Submit a Letter of Intent
  4. Submit an application (if invited)

Applicant Resources

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