This PCORI funding announcement invites applications for high-quality comparative effectiveness research (CER) 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, requiring funding in excess of $10 million in direct costs. The proposed trials should address important 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 study.

This funding announcement anticipates that the proposed research projects will require an initial feasibility phase with funding support for study refinement, feasibility testing, stakeholder engagement, and infrastructure establishment. Findings of the feasibility phase should enable rapid and successful continuation to a second phase for the conduct of the full-scale or main research study. The feasibility phase may include, but is not limited to, the development and initiation of a robust stakeholder engagement plan, piloting of data collection methods, refinement of recruitment methods and estimated enrollment, or the establishment of study sites. Continued funding of the second phase to carry out the full-scale study will be contingent upon the achievement of specific milestones and deliverables in the feasibility phase.