Broad Pragmatic Studies Grant Program

The Patient-Centered Outcomes Research Institute (PCORI) is offering the Broad Pragmatic Studies PFA to support high-impact, patient-centered comparative clinical effectiveness research projects. The funding opportunity is connected to PCORI's Research Project Agenda and its Topic Themes. Applicants may identify up to three Topic Themes that align with their proposed research, although alignment with a Topic Theme is not required. PCORI uses the themes to help determine the optimal review pathway for proposed research. For Cycle 3, PCORI also identifies Special Areas of Emphasis intended to encourage, rather than restrict, submissions in selected research areas. PCORI strongly encourages individual or cluster randomized controlled trials, while also allowing well-specified natural experiments and well-designed observational studies. Proposed studies should have sample sizes sufficient to provide precision in estimating hypothesized effect sizes and, when appropriate, examining heterogeneity of treatment effect. Applicants are encouraged to address intervention implementation in ways that can facilitate broad uptake of findings, including hybrid effectiveness-implementation approaches. Strict implementation or dissemination studies and studies focused on developing research methods are not considered responsive. Proposed outcomes should be well justified, validated, clinically meaningful, important to patients, and capable of being affected by the interventions during the study period. Applicants should consider the full range of relevant clinical and patient-centered outcomes. Cycle 3 Special Areas of Emphasis include improving mental health and substance use outcomes for pregnant and postpartum populations; cancer survivorship; diabetes prevention, care and treatment; management of neuropathic pain; and management of pain among individuals living with intellectual and developmental disabilities or Alzheimer's disease and related dementias. These areas are intended to encourage submissions and do not limit applicants to these subjects. PCORI also expects patients and other research partners to meaningfully contribute lived experience or professional expertise so that funded studies are patient-centered, relevant and useful for healthcare decision making. Applicants must address PCORI's Foundational Expectations for Partnerships in Research and are strongly encouraged to consider a broad range of patient-centered burdens and economic outcomes. The opportunity provides three funding categories and PCORI will commit up to $120 million in direct costs. Category 1 supports projects with direct costs up to and including $5 million. Category 2 supports projects with direct costs greater than $5 million and up to $12 million; applicants seeking Category 2 funding must provide additional information in both the Letter of Intent and application explaining and justifying the project's size, scope, complexity, personnel and material resource needs. Category 3 supports projects with direct costs up to $12 million that use PCORnet to conduct observational studies and/or pragmatic trials that are national in scale. Category 3 PCORnet Studies must include at least two Clinical Research Networks, share study progress, performance metrics and best practices with the network, and leverage the PCORnet Common Data Model as appropriate. Projects may have a duration of up to five years. Applicants in all categories may request coverage of patient care costs, including medical products, procedures and care services, but these expenses count toward the overall direct cost maximum and funding of requested patient care costs is not assured. Applicants may also propose structured mentorship activities for early- or mid-career investigators, investigators transitioning to patient-centered comparative clinical effectiveness research, and patient or community partners. Such requests must satisfy criteria detailed in the PFA, and PCORI funding for mentorship activities is not assured. No matching or cost-sharing requirement is stated in the supplied funding information. The PFA opens August 4, 2026. An Applicant Town Hall is scheduled for August 13, 2026 at 11:30 am ET. A Letter of Intent is required by September 9, 2026 at 5 pm ET, followed by LOI status notification on October 14, 2026. The full application deadline is January 12, 2027 at 5 pm ET. PCORI has launched PCORI Connect as its portal for applying for funding opportunities. Applicants who submit an LOI and are invited to submit a full application may request one deferral to the immediate next PFA cycle, including across cycle years when applicable. The supplied information does not state a final award notification date or project start date. Questions about the Cycle 3 Broad Pragmatic Studies funding announcement may be sent to pfa@pcori.org. PCORI's general office phone number is (202) 827-7700.

Demonstrate a critical comparative clinical effectiveness evidence gap and a clear decisional dilemma; compare at least two alternatives supported by evidence of efficacy, effectiveness, or widespread use; use rigorous fit-for-purpose pragmatic methods and comply with applicable PCORI Methodology Standards; describe comparators clearly and justify usual care when used; use validated and clinically meaningful patient-centered outcomes; demonstrate meaningful early and ongoing patient and stakeholder engagement rather than input-only engagement; establish feasibility, representative recruitment, realistic milestones, and potential for findings to be adopted into practice; for requests above 5 million dollars, strongly justify scale, resources, generalizability, and subgroup analyses; strictly follow templates, formatting, page limits, deadlines, and budget limits because noncompliance can result in rejection