Notice of Upcoming PCORI Funding Announcement

Key Dates

  • PFA Opens
    May 7, 2024
  • Applicant Town Hall
    View recorded webinar/slides
  • 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 PCORI Funding Announcement (PFA) on May 7, 2024, seeking to fund studies that address high-priority methodological gaps in patient-centered comparative clinical effectiveness research (CER). 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.

PCORI seeks to fund projects that address important methodological gaps and lead to improvements in the strength and quality of evidence generated by CER studies.

For the 2024 Methods PFA, PCORI has identified the following areas as program priorities:

  • Methods to Improve the Use of Artificial Intelligence (AI) and Machine Learning (ML) in Clinical Research
  • Methods to Improve Study Design
  • Methods to Support Data Research Networks
  • Methods Related to Ethical and Human Subjects Protections Issues in CER

Update for the 2024 Methods PFA

  • Beginning in Cycle 1 2024, PCORI has changed the title of this PFA from “Improving Methods for Conducting Patient-Centered Outcomes Research (PCOR)” to “Improving Methods for Conducting Patient-Centered Comparative Clinical Effectiveness Research.” This change more accurately reflects PCORI's interest in funding studies that address methodological gaps in the full scope of CER studies. There are no substantive changes to the PFA related to this title change.
  • To Improve the Use of Artificial Intelligence (AI) and Machine Learning (ML) in Clinical Research
    • Beginning in Cycle 1 2023, PCORI no longer considers projects that develop disease- or condition-specific predictive models for this opportunity.
    • Beginning in Cycle 3 2023, this program priority area includes proposed methodological innovations related to large language models (LLMs).
  • To Improve Study Design
    • Beginning in Cycle 2 2023, PCORI no longer considers applications in the area of the design and conduct of cluster randomized trials, including stepped-wedge trials. PCORI is currently funding several projects in this area. PCORI may reintroduce cluster randomized trials as a priority in future funding cycles.
    • Beginning in Cycle 2 2023, this program priority includes a call-out regarding methods to improve the design and conduct of decentralized clinical trials (DCTs).
  • Integration of PCORI’s Topic Themes
    • Beginning in Cycle 3 2023, the Methods PFA includes a set of Topic Themes that inform PCORI’s funding opportunities over the next several cycles. The 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.
    • Addressing these Topic Themes in a Methods proposal is encouraged but not required; addressing one of the four program priorities listed above remains required for a proposal to be considered responsive.

Standing 2024 Methods PFA

Continuing the practice started with Cycle 1 2022, PCORI posts all submission materials for the Methods PFAs and opens PCORI Online for the Letter of Intent (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 PFAs, 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 of the 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 Methods PFA details and address policy changes. 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. PCORI will also clearly indicate on the PFA web page if no changes have been made since the prior cycle posting.

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
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
$12 million
Total Direct Costs
Up to $750,000
Maximum Project Period
Up to three years

Tags

Year
Award Types
Cycle
Status