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.