Notice of Upcoming PCORI Funding Announcement

Key Dates

  • PFA Opens
    May 7, 2024
  • Applicant Town Hall
    May 17, 2024; 11:30 am (ET)
  • Letter of Intent (LOI) Deadline
    June 4, 2024; 5 pm (ET)
  • LOI Status Notification
    July 2, 2024
  • Application Deadline
    Sept. 4, 2024; 5 pm (ET)

The Patient-Centered Outcomes Research Institute (PCORI) intends to release a Broad Pragmatic Studies (BPS) PCORI Funding Announcement (PFA) on May 7, 2024, which seeks to fund applications for high-quality patient-centered comparative clinical effectiveness research (CER) projects. This preannouncement is provided to allow potential applicants additional time to identify collaborators; obtain patient and stakeholder input on potential studies; and develop responsive, high-quality proposals.

All applications must align the proposed research with at least one of the 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). 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 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, guiding PCORI 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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descriptions for PCORI's national priorities for health

The National Priorities for Health build on PCORI’s longstanding funding framework of research approaches to improve patient-centered health through 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


PCORI Topic Themes of interest that inform PCORI’s funding opportunities over the next several cycles. PCORI’s Topic Themes speak to everyday health issues facing large numbers of people in the United States including children, youth, and older adults and address urgent topics such as substance use, mental and behavioral health, violence and trauma, as well as widespread conditions including cardiovascular disease, pain management, and sleep health. These themes include four key topics that have been important interest areas for PCORI—preventing maternal morbidity and mortality, improving outcomes for people with intellectual and developmental disabilities (IDD), addressing COVID-19, and addressing rare disease. 

Applicants to the Cycle 2 2024 BPS PFA may select up to three of PCORI’s 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 patient-centered CER. In keeping with past cycles, the BPS PFA welcomes all investigator-initiated, patient-centered CER.

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Special Areas of Emphasis


For Cycle 2 2024, PCORI has identified Special Areas of Emphasis (SAEs) within the BPS funding opportunity to support innovative, high-impact studies that fit clearly within our core mission of patient-engaged and patient-centered CER.

The purpose of calling out these SAEs is to encourage submissions to these areas, not to limit submissions to these topics. Applicants addressing an SAE must identify which of the listed areas of research is best associated with their research approach.

  • Post-Traumatic Stress Disorder: PCORI is interested in supporting research to test the comparative clinical effectiveness of treatment options for post-traumatic stress disorder (PTSD). Of particular interest are studies including children and youth, veterans and civilian adults with varying types of trauma. Studies focused on comparing strategies to enhance delivery of PTSD care outside of specialty mental health settings and advancing health equity are especially encouraged.
  • Improving Health and Quality of Life in Down Syndrome: People with Down syndrome are more likely to experience co-occurring conditions like obesity and cardiovascular disease, although there is a lack of evidence on whether treatment approaches developed for the general population are also effective in individuals with Down syndrome. PCORI is interested in comparing interventions to improve the health and well-being of individuals with Down syndrome, particularly in approaches addressing mental health/well-being, cardiovascular disease, obesity, diabetes, obstructive sleep apnea and Alzheimer’s disease. Research can be conducted in clinical or community settings, and interventions can be at the individual and/or system level.
  • Peripheral Arterial Disease: PCORI is interested in supporting research in diagnostic and therapeutic options for patients with either intermittent claudication and/or critical limb ischemia. Although submissions are not limited to these topics, areas of interest to PCORI include reducing disparities in care, systems-level comparisons for optimal treatment, direct comparisons of non-surgical treatment options, comparisons of screening approaches and options to promote long term treatment adherence.
  • Functional Sensory Impairment in Older Adults: PCORI is interested in patient-centered CER projects focused on older adults who experience sensory impairments associated with aging — more specifically, hearing or visual impairment. Areas of interest include studies proposing to compare different screening and follow-up strategies to promote early detection and management strategies, both of which address important decisional dilemmas faced by patients and their caregivers. Interventions in diverse healthcare settings and within underserved populations experiencing disparities in both access and in outcomes are also especially encouraged.

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.

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 2023 and Cycle 1 2024 BPS PFAs will be considered eligible to submit to the Cycle 2 2024 BPS PFA.

Standing 2024 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 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 patient and stakeholder interests, PCORI may revise the BPS PFA details, address policy changes and add or remove a theme or SAE. Topic Themes and SAEs aim to encourage applications on a particular health topic, not restrict applications to only the themes or SAEs.

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].

View Key Dates for Cycle 2 below. Click here for Key Dates for Cycle 3.

Key Dates

Online System Opens
May 7, 2024
Applicant Town Hall
-
View Event
Letter of Intent Deadline
June 4, 2024
Letter of Intent Status Notification
July 2, 2024
Apply Here
Application Deadline
September 4, 2024, 5 pm (ET)
Merit Review
November 2024
Awards Announced
April 2025
Earliest Start Date
August 2025

Funds and Project Period

Funds Available Up To
Approximately $160 million total for all categories (1, 2 and 3)
Total Direct Costs
Category 1
-- Less than or equal to $5 million in direct costs
Category 2
-- Greater than $5 million; up to $12 million in direct costs
Category 3
-- Up to $12 million in direct costs
Maximum Project Period
Up to five years for all categories (1, 2 and 3)

Cycle 3 2024 Key Dates

Online System OpensSept. 4, 2024
Letter of Intent (LOI) DeadlineOct. 1, 2024, 5 pm (ET)
LOI Status NotificationOct. 29, 2024
Application DeadlineJan. 14, 2025, 5 pm (ET)

Tags

Year
Health Conditions Health Conditions These are the broad terms we use to categorize our funded research studies; specific diseases or conditions are included within the appropriate larger category. Note: not all of our funded projects focus on a single disease or condition; some touch on multiple diseases or conditions, research methods, or broader health system interventions. Such projects won’t be listed by a primary disease/condition and so won’t appear if you use this filter tool to find them. View Glossary
Populations Populations PCORI is interested in research that seeks to better understand how different clinical and health system options work for different people. These populations are frequently studied in our portfolio or identified as being of interest by our stakeholders. View Glossary
Award Types
Cycle
Status