Improving Methods for Conducting Patient-Centered Outcomes Research -- 2023 Standing PFA (Cycle 3 2023)

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) and that. lead to improvements in the strength and quality of evidence generated by patient-centered 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 patient-centered 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.
• Beginning in Cycle 3 2023, this programmatic priority area includes proposed methodological innovations related to large language models (LLMs).
• 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).

• Integration of PCORI’s Topic Themes:  

  • Beginning in Cycle 3 2023, the Methods PFA will integrate 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 programmatic priorities listed above remains required for a proposal to be considered responsive. 

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.