With this PCORI Funding Announcement (PFA), PCORI aims to fund studies that address high-priority methodological gaps in patient-centered outcomes research (PCOR) and clinical comparative effectiveness research (CER).

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

For the 2023 Methods PFA, PCORI has identified the following areas as programmatic 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 PCOR/CER

Update for the 2023 Methods PFA

• To Improve the Use of Artificial Intelligence (AI) and Machine Learning (ML) in Clinical Research:
  • Beginning in Cycle 1 2023, PCORI will consider projects that develop disease- or condition-specific predictive models to be nonresponsive.
• To Improve Study Design:
  • Beginning in Cycle 2 2023, PCORI will no longer consider 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. We may reintroduce cluster randomized trials as a priority in future funding cycles.
  • Beginning in Cycle 2 2023, this programmatic priority includes a call-out regarding methods to improve the design and conduct of decentralized clinical trials (DCTs).

Standing 2023 Methods PFA

Continuing the practice started with Cycle 1 2022, PCORI posts all submission materials for the Methods PFAs and open PCORI Online for the Letter of Intent (LOI) phase of application submission at the start of the 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 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 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 webpage if no changes have been made since the prior cycle posting.