This PCORI Funding Announcement (PFA) invites applications for high-quality comparative clinical effectiveness research (CER) projects.
All applications must align the proposed research with at least one of PCORI’s National Priorities for Health described within the PFA (Increase Evidence for Existing Interventions and Emerging Innovations in Health; Accelerate Progress Toward an Integrated Learning Health System; Achieve Health Equity; or Advance the Science of Dissemination, Implementation and Health Communication). Research Project Agenda Topic Themes are also included in this funding opportunity. Applicants have the option to choose up to three Topic Themes based on how their proposed research aligns with the themes. However, aligning with a Topic Theme is not required. The National Priorities for Health and Research Project Agenda Topic Themes will assist PCORI in determining the optimal review pathway for the proposed research.
National Priorities for Health
PCORI’s National Priorities for Health are a comprehensive set of mutually reinforcing goals that focus on impact and drive research funding and other initiatives to improve patient care and health outcomes. The breadth of the goals allows for flexibility, agility and responsiveness to foreseen and unforeseen changes in the healthcare landscape. The National Priorities for Health were developed, revised and finalized with extensive stakeholder input.
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Applicants should be able to recognize how their proposed patient-centered CER may serve and align with one or more of the National Priorities for Health. For example, research to help Achieve Health Equity may compare existing and emerging evidence-based innovations in health system delivery, making use of alternative health communication methods to increase access to care for historically underserved and under-researched populations. This example illustrates how a research study can have multiple connections to PCORI’s National Priorities for Health.
New Engagement Resource and Expectations: PCORI's Foundational Expectations for Partnerships in Research
PCORI released updated guidance for engagement in research, PCORI's Foundational Expectations for Partnerships in Research. Project teams are expected to address the Foundational Expectations when applying for PCORI research funding, developing project and engagement plans for awarded projects, and reflecting on engagement during a project to improve and strengthen engagement over time. There will be flexibility in how applicants address the Foundational Expectations. View these FAQs about the Foundational Expectations and view additional information, guidance and resources.
Research Project Agenda Topic Themes
PCORI's Research Project Agenda includes a set of Topic Themes that inform focused funding opportunities for patient-centered CER through a series of funding cycles. This set of Topic Themes evolves over time to promote PCORI funding across the full range of health issues and conditions faced by the U.S. population.
Applicants to the Cycle 1 2025 BPS PFA may select up to three of PCORI’s Research Project Agenda Topic Themes that best align with their proposed research. Applicants may also opt not to select from the PCORI Research Project Agenda Topic Themes and select “other” to indicate that their research aligns with other areas of important need for patient-centered CER. In keeping with past cycles, the BPS PFA welcomes all investigator-initiated, patient-centered CER.
Special Areas of Emphasis
For Cycle 1 2025, PCORI has identified Special Areas of Emphasis (SAEs) within the BPS funding opportunity. The purpose of calling out these SAEs is to encourage submissions to these areas, not to limit submissions only to these topics. Applicants addressing an SAE must identify which of the listed areas of research is best associated with their research approach.
- Social Isolation and Loneliness in Older Adults
PCORI is interested in supporting high quality patient-centered CER testing the impact of interventions to address social isolation and loneliness in older adults. These interventions are required to have been shown to be efficacious or in widespread use and may include interventions for other health conditions that could be adapted to address social isolation and loneliness. Of particular interest are large, multi-site, randomized studies of interventions in various settings such as community-based services settings, long-term care facilities or healthcare settings. Although not required, interventions targeting historically under-resourced and/or marginalized populations or subgroups with specific conditions (e.g., sensory impairment, functionally disabled, limited mobility) are encouraged. Studies must include a mental health outcome as a primary, co-primary, or secondary outcome. - Health Communication Strategies for Uptake of COVID-19 Vaccine
PCORI is interested in supporting high-quality, patient-centered CER projects comparing health communication strategies to promote COVID-19 vaccine uptake among U.S. adults and children. Other vaccines may also be incorporated along with COVID-19. Additional outcomes of interest include vaccine confidence, vaccine knowledge and vaccine-related shared decision making. While interventions can be targeted to any patient or provider population (or the patient-provider relationship), PCORI is especially interested in research focused on the following populations: individuals with intellectual and developmental disabilities; older adults, including those with cognitive impairments; and individuals from the most affected racial and ethnic groups.
Broad Pragmatic Studies PFA: Category 1, Category 2 and Category 3 Study Specifications
PCORI will commit up to $160 million per cycle through this funding opportunity. The BPS PFA will offer three categories based on award size and requirements. All applications, regardless of category, must align the proposed research with at least one of the four National Priorities for Health described within the PFA.
Category 1
- Category 1 will support research projects with direct costs up to and including $5 million.
Category 2
- 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 expected to justify the proposed research's size and scope and why additional funds are necessary to support the scale, scope and complexity of personnel and material resources needed to address the research question.
Category 3
- 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. Additional details about Category 3 can be found on the PCORI website.
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.
Structured Mentorship
All applicants submitting to this PFA may propose coverage of structured mentorship activities for early- or mid-career investigators, or investigators whose lived experiences, perspectives or backgrounds are underrepresented in research. 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
PCORI has transitioned its pilot deferral process for application submissions to a standing policy, which is applicable to this PFA. This policy allows applicants who have submitted a Letter of Intent (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 1 2025 BPS funding announcement, please reach out to pfa@pcori.org.
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