Are preliminary results or pilot studies required to have a successful application? To what extent is it acceptable to propose engagement and/or designs without any prior history?

There are no explicit requirements regarding pilot data in order to be eligible for PCORI funding. PCORI will consider funding applicants who have not conducted preliminary research or pilot studies. However, it is recommended that applicants who do not include pilot or preliminary data in their applications clearly explain the reason(s) for not including such data. Please see the “Guidance for Proposing Research” and “Research Priorities” sections in the PFA for more information. As with any research application, feasibility of key aspects of the research is important to demonstrate, and for some projects, pilot data may be an appropriate way to communicate feasibility of the proposed research plan.

A history of engagement with the proposed research partners is not required; however, it is encouraged if applicable to the particular study. Prior work with research partners should be noted because these learnings should inform the application. For some studies, demonstrated commitment of patients or other stakeholders may be appropriate; for other studies, a plan for engaging end-users may be appropriate.