Broad Pragmatic Studies PCORI Funding Announcement -- Cycle 3 2026

Broad Pragmatic Studies PCORI Funding Announcement -- Cycle 3 2026 is sponsored by Patient-Centered Outcomes Research Institute (PCORI). This PFA from PCORI supports broad pragmatic studies in patient-centered comparative clinical effectiveness research (CER). These studies compare at least two available health interventions to determine what works best for different patients in real-world settings.

* **Applicant Town Hall** * **Letter of Intent (LOI) Deadline** * **LOI Status Notification** * **Application Deadline** This PCORI Funding Announcement (PFA) invites applications for high-impact patient-centered comparative clinical effectiveness research (CER) projects. PCORI’s Research Project Agenda includes a set of Topic Themes that are included in this funding opportunity and further detailed below.

Applicants have the option to choose up to three Topic Themes within the Research Project Agenda based on how their proposed research aligns with the themes. However, aligning with a Topic Theme is not required. The Topic Themes will assist PCORI in determining the optimal review pathway for the proposed research.

Applicants are strongly encouraged to propose individual or cluster randomized controlled trials; however, well-specified natural experiments and well-designed observational studies will also be considered. Proposed studies should include an overall sample size that will allow precision in the estimation of hypothesized effect sizes and, as appropriate, analysis of heterogeneity of treatment effect.

Applicants are encouraged to pay special attention to issues of intervention implementation with an aim of facilitating widespread uptake of findings after completion of the study by utilizing hybrid effectiveness-implementation approaches. However, strict implementation or dissemination studies will not be considered responsive, nor will studies focused on the development of research methods.

Applicants should propose well-justified and validated outcomes that are clinically meaningful and considered important by patients, and that can be impacted by the proposed interventions within the study duration. Applicants should consider, as appropriate, the full range of clinical and patient-centered outcomes data relevant to patients and other stakeholders.

PCORI’s Principles for the Consideration of the Full Range of Outcomes Data in PCORI-Funded Research inform the expectations for applicants and the corresponding evaluation of applications submitted in response to this PFA. ## Special Areas of Emphasis For Cycle 3 2026, PCORI is particularly interested in submissions that address the following Special Areas of Emphasis (SAE) within the BPS funding opportunity.

The purpose of identifying these SAEs is to encourage submissions to these areas, not to limit submissions to these topics.

Applicants addressing one of the below SAEs should identify the area that is best associated with their research approach: * **Improving Mental Health and Substance Use Outcomes for Pregnant and Postpartum Populations:** PCORI is interested in supporting high-quality, patient-centered comparative clinical effectiveness research (CER) projects comparing interventions shown to be efficacious or in widespread use that address mental health and substance use during pregnancy and the postpartum period (up to 12 months).

Of particular interest are studies focused on comparing pharmacological approaches for perinatal mental health management, suicide prevention strategies and substance use treatment tailored for the perinatal population. If retrospective observational studies are proposed, PCORI encourages those submissions to have a Category 1 budget.

Although not required, a focus on populations experiencing high maternal health-related burdens and practice variations in maternal care and outcomes or subgroups with comorbidities is encouraged. * **Cancer Survivorship:** PCORI is interested in the comparative clinical effectiveness of different models of post-treatment, follow-up care across different survivor populations.

These models may include risk-based, stratified approaches as well as approaches to integrate rehabilitation and mental health services as part of follow-up care. Of particular interest are studies focusing on adolescent and young adult survivors, older cancer survivors with multiple chronic conditions, metastatic cancer survivors and long-term cancer survivors.

Studies that focus on cancer survivorship in remote or rural settings and studies focusing on care transitions from pediatric to adult care settings and transitions from completion of primary treatment to follow-up care are also of interest.

* **Diabetes Prevention, Care and Treatment:** PCORI is interested in funding high-quality, patient-centered comparative effectiveness research (CER) on the prevention, care and treatment of individuals with diabetes and prediabetes.

This includes studies comparing pharmacological interventions, including combination therapies; multi-component approaches that integrate lifestyle and medication strategies; and the use of advanced diabetes technologies, such as continuous glucose monitoring and automated insulin delivery systems.

PCORI is also interested in research evaluating different care delivery and coordination models across settings and populations, including individuals with multiple chronic conditions, to improve outcomes, access and patient-centered decision-making.

* **Management of Neuropathic Pain:** PCORI is interested in funding patient-, practitioner- and/or systems-level CER comparing strategies aimed to improve screening, diagnosis, treatment and management of pain associated with neuropathy, including but not limited to painful diabetic neuropathy and neuropathy resulting from cancer treatments. The inclusion of at least one validated primary outcome focused on pain is highly encouraged.

* **Management of Pain in Individuals Living With Intellectual and Developmental Disabilities or Alzheimer's Disease and Related Dementias:** PCORI is interested in funding patient-, practitioner- and/or systems-level CER comparing strategies aimed to improve prevention, screening, diagnosis, treatment and management of pain among people living with Intellectual and Developmental Disabilities or Alzheimer’s Disease and Related Dementias.

The inclusion of at least one validated primary outcome focused on pain is highly encouraged. In PCORI-funded research, patients and other research partners are expected to meaningfully contribute their lived experience or professional expertise to ensure studies are patient-centered, relevant and useful for healthcare decision making.

Applicants must address PCORI’s Foundational Expectations for Partnerships in Research — an evidence-based framework supported by tools and resources to guide effective engagement strategies. View additional details on each of the Foundational Expectations. Applicants are also strongly encouraged to consider the inclusion of a broad range of patient-centered burdens and economic outcomes.

This funding announcement will accept applications with direct costs up to $12 million and up to five years in duration. For this funding announcement, applicants may request coverage of patient care costs (including medical products, procedures and care services) for potential funding by PCORI. These costs are included as part of the overall direct cost maximum.

For additional information, please see the full announcement. ## Broad Pragmatic Studies PFA: Category 1, Category 2 and Category 3 Study Specifications PCORI will commit up to $120 million in direct costs through this funding opportunity. This funding opportunity contains three categories for funding: * Category 1 will support research projects with direct costs up to and including $5 million.

* Category 2 will support research projects with direct costs greater than $5 million and up to a maximum of $12 million.

Applications for funding under Category 2 will be required to provide additional information in the Letter of Intent (LOI) and application to justify the size and scope of the proposed research projects and to explain how additional funds are necessary with respect to the scale, scope and complexity of personnel and material resources needed to address the research question.

* Category 3 will support research projects with direct costs up to $12 million that utilize PCORnet® to conduct observational studies and/or pragmatic trials that are national in scale. Category 3 PCORnet Studies® must include two or more Clinical Research Networks and share study progress, performance metrics and best practices with the network to promote continuous learning and improvement.

PCORnet Studies® will leverage the PCORnet Common Data Model® as appropriate. View additional details about Category 3. ## Coverage of Patient Care Costs All applicants submitting to this PFA may request coverage of patient care costs.

Coverage of these costs will be subject to meeting specified criteria that PCORI will use to determine which costs, if any, may be acceptable for potential funding. PCORI funding for requested patient care costs is not assured.

All applicants submitting to this PFA may propose coverage of structured mentorship activities for early- or mid-career investigators, investigators making a career transition to patient-centered CER and/or patient and community partners. As detailed further in the PFA, applicants must address specific criteria for potential funding. PCORI funding for requested structured mentorship activities is not assured.

## Application Deferral Policy This policy allows applicants who have submitted an LOI and are invited to submit a full application to defer their application submission **once** to the immediate next PFA cycle. This request may cross cycle years, if applicable. For questions regarding the Cycle 3 2026 BPS funding announcement, please contact pfa@pcori.

org. * Is Your CER Study Responsive to PCORI’s Funding Announcements?

* What You Need To Know To Apply * Foundational Expectations for Partnerships in Research * PCORI’s Portfolio of Funded Research * Population Insights Reports Powered by PCORnet® Download Full Announcement Letter of Intent Deadline Letter of Intent Status Notification August 2027 (Subject to Change) ## Funds and Project Period $120 million total for all categories (1, 2 and 3) -- Less than or equal to $5 million in direct costs -- Greater than $5 million; up to $12 million in direct costs -- Up to $12 million in direct costs Up to five years for all categories (1, 2 and 3) ## To Apply for This Opportunity 1.

Read the full Broad Pragmatic Studies PFA and FAQs. 2. Use the Application Readiness Checklist.

3. Submit a Letter of Intent (LOI) through PCORI Connect. * All new and returning applicants will use the new PCORI Connect submission portal, which has built-in templates (for most PFAs) and resources for a streamlined experience.

* PCORI Connect Help Center 4. Submit an application, upon invitation only, through PCORI Connect. * Application submission requires LOI acceptance and invitation by PCORI to submit a proposal.

Additional Applicant Resources