This PCORI Funding Announcement (PFA) invites applications for high-quality, comparative effectiveness research projects that will examine a critical patient-centered research question that is also relevant to decision makers and other stakeholders. For this PFA, investigators should propose an individual-level or cluster randomized controlled trial of significant scale and scope. The proposed trials should address critical decisional dilemmas that require important new evidence about the comparative effectiveness of available interventions. Proposed studies should compare interventions that already have established evidence of efficacy or are in widespread use. Clinical interventions (such as medications, diagnostic tests, or procedures) and delivery system interventions are appropriate for these studies.

This funding announcement anticipates that proposed research projects will require two phases of funding support with initial funding of a distinct feasibility phase for purposes of study refinement, infrastructure establishment, 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 is not permitted. Approval to continue to the second phase will be contingent on achieving specific milestones and deliverables established for the feasibility phase.

In light of the scale, complexity, and scope of studies being solicited under this PFA, PCORI requires that applications include a data coordinating center with an independent role in study leadership to advise on the analytical, statistical, and data management aspects of both study phases.

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.

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Key Dates

Online System Opens
September 7, 2021, 9:00 AM
Applicant Town Hall
View Event
Letter of Intent Deadline
October 5, 2021, 5:00 PM
Application Deadline
January 11, 2022, 5:00 PM
Merit Review
April 2022
Awards Announced
Earliest Start Date
November 2022

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)


Award Types