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Improving Methods for Conducting Patient-Centered Comparative Clinical Effectiveness Research PCORI Funding Announcement -- Cycle 2 2026

Patient-Centered Outcomes Research Institute

The Patient-Centered Outcomes Research Institute (PCORI) intends to issue an Improving Methods for Conducting Patient-Centered Comparative Clinical Effectiveness Research (Methods) PCORI Funding Announcement (PFA) on April 1, 2026, seeking to fund studies that address high-impact methodological gaps in patient-centered comparative clinical effectiveness research (CER). This preannouncement provides potential applicants additional time to identify collaborators; obtain patient and stakeholder input on potential studies; and develop responsive, high-quality applications.

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 Cycle 2 2026 Methods PFA, PCORI has identified the following areas as program priorities:

Methods To Support the Use of Patient-Centered Measurement in Patient-Centered CER (NEW)
Methods To Support the Use of Real-World Data (RWD) in Multi-Site Patient-Centered CER (formerly Methods To Support Data Research Networks)
Methods To Improve the Use of Artificial Intelligence (AI) and Machine Learning (ML) in Patient-Centered CER
Methods To Improve Study Design in Patient-Centered CER

This funding announcement will accept applications with direct costs of up to $750,000 and up to three years in duration.

What’s New for Cycle 2 2026

Introduction of the “Patient-Centered Measurement” programmatic priority, with topics including but not limited to:
- methods to develop, validate or apply standardized approaches for measuring patient-centered burdens and economic outcomes (PCBEOs);
- methods for harmonizing, linking, comparing or synthesizing data from different but related measurement instruments used across diverse settings, populations or time points; and
- methods for improving the measurement and analysis of contextual factors and mediators relevant to patient-centered outcomes.
“Methods Related to Ethical and Human Subjects Protections Issues in Patient-Centered CER” will be retired as a stand-alone programmatic priority and integrated across the other priorities. PCORI maintains a strong programmatic interest in this research area.
New topics added to the “Methods To Support the Use of RWD in Multi-Site Patient-Centered CER” priority, including methods to generate, validate and apply synthetic data based on RWD to support CER, and methods to improve outcome measurement using RWD, including data from digital health technologies.
New topics added to the “Methods To Improve the Use of AI/ML in Patient-Centered CER” priority, including applications of AI/ML to augment or transform research methodologies or processes, and approaches using AI/ML to enhance health communication.

Key Dates

Online System Opens

April 1, 2026, 9 am (ET)

Applicant Town Hall

Apr. 6, 2026; 12 - 1 pm (ET)

View Event

Letter of Intent Deadline

April 28, 2026, 5 pm (ET)

Letter of Intent Status Notification

June 2, 2026, 5 pm (ET)

Application Deadline

Sept. 1, 2026, 5 pm (ET)

Merit Review

November 2026

Awards Announced

April 2027 (Subject to Change)

Earliest Start Date

August 2027

Funds and Project Period

Funds Available Up To

$12 million

Budget

Up to $750,000

Maximum Project Period

Up to three years

AI based application success predictor

🧠 1. Clear Patient-Centered Focus

PCORI emphasizes questions and outcomes that matter to patients and caregivers — such as symptom relief, quality of life, care experience, and decision making — rather than exclusively surrogate or laboratory endpoints. PCORI
Tip: Define research questions in terms of patient priorities, not just scientific interest.

🤝 2. Engagement of Patients & Stakeholders

A hallmark of PCORI’s Merit Review is explicit requirements for meaningful involvement of patients, caregivers and other stakeholders during proposal development, design and execution. Engagement is a distinct criterion reviewers consider alongside scientific merit. ScienceDirect
Tip: Build stakeholder engagement plans that demonstrate how patients/communities will influence key decisions (choice of comparators, outcomes, recruitment strategies).

🔍 3. Comparative Effectiveness Design

PCORI requires that studies compare two or more care options relevant to real healthcare decisions — this is central to eligibility. PCORI
Tip: Ensure the comparison (e.g., two treatments, delivery strategies, screening options) reflects real choices patients/clinicians face.

📊 4. Methodological Rigor & Feasibility

Competitive proposals have robust study designs, clear definitions of outcomes and analyses that support valid comparisons, with realistic timelines and scalable recruitment plans. PCORI
Tip: Develop rigorous plans tailored to CER, including statistical methods and pragmatic implementation plans.

📅 5. Alignment With Specific PFA Priorities

Each PFA has defined scope and priorities (e.g., methods for engagement; implementation in health systems). Applications must match the language and goals of the specific funding announcement. PCORI
Tip: Tailor aims to the exact PFA requirements rather than submitting generic CER designs.

📣 6. Dissemination & Uptake Planning

Projects that include clear dissemination and implementation plans — describing how results will be shared with patients, clinicians, health systems, or policymakers — score stronger on relevance and impact. PCORI
Tip: Include strategies for uptake, such as integration into clinical guidelines, digital tools, or decision aids.

📑 7. Organizational Capacity & Collaboration

Because PCORI awards are often larger and multi-site, reviewers value organizational experience in complex CER, including data systems, partnerships with clinical sites or community networks, and multidisciplinary teams. PCORI
Tip: Demonstrate infrastructure for recruitment, data management, and stakeholder engagement.

📌 Practical Application Tips

✔ Start early & follow cycles: PCORI issues repeated funding opportunity cycles (e.g., spring, fall). PCORI
✔ Use PCORI resources: Attend webinars and use application guides and templates provided on the PCORI website. PCORI
✔ Engage stakeholders early: Integrate patient partners before LOI submission to shape the research question. ScienceDirect
✔ Monitor announcements: Subscribe to PCORI emails for updates on new PFAs and registry of funded projects. PCORI

🧠 Summary: PCORI Competitive Funding

Success Predictor	Why It Matters
Patient-Centered Focus	Core mission of PCORI; shapes review. PCORI
Stakeholder Engagement	Engagement is a standalone review criterion. ScienceDirect
Comparative Design	Must compare options relevant to patients. PCORI
Methodological Quality	Ensures credible, useful conclusions. PCORI
Alignment With PFA Scope	Match to solicitation goals. PCORI
Dissemination & Implementation Plan	Enhances real-world impact. PCORI
Organizational Capacity	Supports execution of complex CER.

Specialties

Clinical Trials

Eligibility Requirements

Organizations, not individuals: Eligible applicants include universities, hospitals, research institutes, healthcare systems, nonprofit community groups and similar entities. Individuals may NOT directly apply. PCORI

PCORI requires applicants to use its online submission system (PCORI Online) for Letters of Intent (LOIs) and full applications and to meet published deadlines.

Sponsor Details

Sponsor Institute/Organizations: Patient-Centered Outcomes Research Institute

Sponsor Type: Corporate/Non-Profit

Address: 1333 New Hampshire Avenue NW, Suite 1200 Washington, DC 20036 Phone: (202) 827-7700 | Fax: (202) 355-9558

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