| This PCORI Funding Announcement is under Cycle 2 2023. |
This PCORI Funding Announcement (PFA) invites applications for high-quality comparative clinical effectiveness research projects. The Broad Pragmatic Studies (BPS) PFA 2023 funding cycle year will retain familiar requirements from the 2022 standing BPS PFA with updates to reflect PCORI’s National Priorities for Health. The BPS PFA was first issued in January 2022 and combined two longstanding funding opportunities known as the Broad PFA and Pragmatic Clinical Studies PFA.
For the 2023 opportunities, PCORI’s National Priorities for Health and Board of Governors-approved Topic Themes have been incorporated. Cycle 2 2023 includes the addition of a Category 3 option to support PCORnet® Studies using PCORnet®, the National Patient-Centered Clinical Research Network, to advance PCORI’s National Priorities for Health. PCORnet is accessible to all investigators interested in using the PCORnet infrastructure, which was designed to improve the nation’s capacity to conduct large-scale patient-centered health research.
All applications must align the proposed research with at least one of the four National Priorities for Health described within the PFA. Twelve 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 the indicated Topic Themes is not required. The National Priorities for Health and Topic Themes will assist PCORI in determining the optimal review pathway for the proposed research.
National Priorities for Health
Adopted by PCORI’s Board in 2021, PCORI’s National Priorities for Health are a comprehensive set of mutually reinforcing goals that focus on impact, guiding our 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.
The National Priorities for Health build on PCORI’s longstanding funding framework of research approaches to improve patient-centered health with comparative clinical effectiveness research (CER). Applicants should be able to recognize how their proposed CER may serve and align with one or more 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.
Topic Themes
In Summer 2022, PCORI’s Board of Governors approved a set of broad Topic Themes to inform PCORI’s funding opportunities over the next several cycles. The themes speak to everyday health issues facing large numbers of Americans, including children, youth, and older adults, and address timely topics such as violence and trauma, substance use, and mental and behavioral health. Cardiovascular health, sleep health, and pain management are also included. The Topic Themes were distilled from public input received from a broad spectrum of stakeholders, including formal public comments made during PCORI’s strategic planning effort.
Applicants to the Cycle 2 2023 BPS PFA may select up to three Topic Themes that best align with their proposed research. Applicants may also opt not to select from the PCORI Topic Themes and select “other” to indicate that their research aligns with other areas of important need for CER. In keeping with past cycles, the BPS PFA welcomes all investigator-initiated CER.
Category 1, Category 2, & 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. This cycle of the 2023 BPS PFA includes the addition of Category 3 to support PCORnet Studies.
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 $10 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 that address PCORI’s National Priorities for Health and Topic Themes by using PCORnet to conduct observational studies and/or pragmatic trials that are national in scale. 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. Category 3 will permit awards for direct costs up to $10 million. Additional details about Category 3 can be found in this PCORI Blog post.
| Category 3 Option Applicant Workshop (May 18; 2:00 pm ET) | Watch the Town Hall |
As mentioned, all applications, regardless of category, must align the proposed research with at least one of the four National Priorities for Health.
Pilot Initiatives: Coverage of Patient Care Costs and Deferrals
The BPS PFA will continue to offer two pilot PCORI initiatives. First, 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. Second, all applicants to the BPS PFA will be able to defer application submissions for invited Letters of Intent (LOIs) for up to two subsequent funding cycles. Researchers who previously elected to defer their PCORI applications from the Cycle 3 2022 and Cycle 1 2023 BPS PFAs will be considered eligible to submit to the Cycle 2 2023 BPS PFA.
Standing 2023 BPS PFA
Continuing the practice started with Cycle 1 2022, PCORI posts all submission materials for the BPS PFA and opens PCORI Online for the LOI phase of application submission at the start of the funding cycle year (i.e., cycles 1–3 of any given year). In addition to the PFA, the Submission Instructions, applicant templates and resources, and cycle deadlines will also be posted on PCORI’s website and available in PCORI Online. Applicants may submit an LOI for any available cycles up until the LOI deadline for that cycle. PCORI will strive to make only necessary administrative updates to the Submission Instructions and applicant templates throughout the cycle year.
To maintain responsiveness to health research needs and stakeholder interests, PCORI may revise the BPS PFA details, address policy changes, and add or remove a theme. Topic Themes aim to encourage applications on a particular health topic, not restrict applications to only the themes.
Announcements of any updates and any revised documents will be posted on PCORI’s website no later than four weeks before each cycle’s LOI deadline. For questions regarding this funding announcement, please reach out to [email protected].
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