This PFA aims to fund 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.
This funding announcement anticipates that the proposed research projects will require an initial feasibility phase before a full-scale trial can proceed. This initial phase will make use of PCORI funding support for study refinement, testing of study operations, stakeholder engagement, and infrastructure establishment to establish the feasibility and merits of continued funding for the full-scale trial’s execution.
In light of the scale, complexity, and scope of studies being solicited under this PFA, PCORI requires that funded trials include a data coordinating center (DCC) with an independent leadership role 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.
