Improving Health Decision Making With Comparative Clinical Effectiveness Research: Retrospective Observational Studies Leveraging Existing Data Sources PCORI Funding Announcement -- Cycle 1 2026

Letter of Intent (LOI) Deadline Jan. 6, 2026; 5 pm (ET)

October 21, 2025

The Patient-Centered Outcomes Research Institute (PCORI) intends to release a new PCORI Funding Announcement (PFA) Dec. 2, 2025 —Improving Health Decision Making With Comparative Clinical Effectiveness Research in Cancer, Pain, Substance Use, Maternal Health, Intellectual and Developmental Disabilities, Sensory Health, Endocrine and Metabolic Health, Mental and Behavioral Health, and Rare Diseases: Retrospective Observational Studies Leveraging Existing Data Sources.  

PFA Overview

This PFA seeks to support well-designed, methodologically robust, retrospective observational patient-centered comparative clinical effectiveness research (CER) that will produce timely, impactful and patient-centered results to inform healthcare decision making and improve health outcomes.

Research Initiative Highlights

  • Applicants must propose a clear comparative effectiveness question by leveraging well-established data sources and infrastructure, such asPCORnet®, ready for patient-centered CER. 
  • Given the retrospective observational nature of this PFA, applications are expected to compare existing interventions that represent a current decisional dilemma and have robust evidence of efficacy or are currently in widespread use. 
  • Clinical interventions (such as medications, diagnostic tests and procedures) and delivery system interventions (such as workforce, technologies and healthcare service delivery designs) are appropriate for these studies.

Funding Details

Budget: Up to $2 million in direct costs 

Duration: Up to 18 months 

 

Topic Themes

All proposed applications must respond to at least one of the following Topic Themes approved by the PCORI Board of Governors:

  • Addressing Cancer 
  • Improving Outcomes for People With Intellectual and Developmental Disabilities
  • Preventing Maternal Morbidity and Mortality
  • Improving Mental and Behavioral Health
  • Improving Metabolic and Endocrine Health
  • Managing Pain
  • Addressing Rare Diseases
  • Addressing Sensory Health
  • Addressing Substance Use

Note: Applications that do not explicitly address at least one of these Topic Themes will be considered nonresponsive. 

Important Dates and Resources

Dec. 2, 2025: Full announcement and application requirements are available atPCORI.org. 

Dec. 10, 2025: Applicant Town Hall, noon-1 pm (ET) —Register today!

For preliminary information, please review the preannouncement on the PCORI website. Questions may be directed to pfa@pcori.org. PCORI encourages sharing this information with others who may be interested.