โ—† ClinicalMetric Research Team ยท Last Reviewed: April 2026 ยท Sources: ClinicalTrials.gov ยท FDA ยท NIH
โ—† Clinical Trial Intelligence โ€” Key Facts
  • โœ“ 400,000+ active trials registered on ClinicalTrials.gov across 200+ countries (2025)
  • โœ“ Only ~12% of drugs entering clinical trials ultimately receive FDA approval
  • โœ“ Average clinical trial takes 6โ€“13 years from Phase 1 to regulatory approval
  • โœ“ ~40% of trials fail to recruit sufficient participants โ€” the #1 reason trials stop early
  • โœ“ All trials must register on ClinicalTrials.gov under the FDA Amendments Act (FDAAA 2007)
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New Opportunity Last Reviewed: April 2026 CM-INS-090 // APRIL 2026

PCORI New Funding Opportunity: Q2 2026 Application Cycle Now Open

Research Notice

This article is for research investigators and institutional administrators seeking PCORI funding. It does not constitute medical advice. All research must follow applicable regulatory requirements including IRB review.

Summary

The Patient-Centered Outcomes Research Institute (PCORI) funds comparative clinical effectiveness research โ€” studies that directly compare existing treatments, care strategies, or health interventions to help patients and clinicians make better-informed decisions. Unlike NIH, PCORI requires meaningful patient and stakeholder engagement throughout the research process โ€” not as an afterthought, but as a core design element. PCORI's Q2 2026 funding opportunities are open across its research portfolio including large Pragmatic Clinical Studies (up to $30M), targeted Evidence Synthesis projects, and Pipeline to Proposal awards for new applicants. Total annual PCORI funding is approximately $500 million.

Current Q2 2026 Funding Opportunities

  • Pragmatic Clinical Studies (PCS): Large-scale comparative effectiveness trials embedded in real-world health care settings. Awards up to $30M over 4โ€“6 years. Require a defined patient population, clinical equipoise between comparison arms, and a pragmatic design that can be conducted within routine care workflows.
  • Patient-Centered Outcomes Research (PCOR) Awards: Smaller comparative effectiveness studies, observational research, or mixed-methods studies addressing patient-centered questions. Awards typically $750,000โ€“$5M over 2โ€“4 years.
  • Evidence Synthesis Awards: Systematic reviews and meta-analyses on comparative effectiveness topics prioritised by PCORI. Awards up to $1.5M. Rapid Evidence Reviews for emerging clinical questions are also funded.
  • Pipeline to Proposal Awards: Capacity-building grants ($50,000โ€“$200,000) designed to help institutions, community organisations, or research teams without prior PCORI funding develop a full application. Priority given to organisations serving underrepresented populations.

PCORI's Patient Engagement Requirement

  • PCORI requires that patients, caregivers, or other stakeholders are meaningfully engaged as partners โ€” not just research subjects โ€” in all funded research
  • Patient partners must be involved in at minimum: research question development, study design, outcome selection, interpretation of results, and dissemination planning
  • Applications must include a detailed Patient and Stakeholder Engagement Plan as a required application section โ€” reviewers assess engagement quality and depth
  • PCORI provides a Patient Engagement Rubric and Checklist โ€” use these to structure and self-assess your engagement plan before submission
  • Patient partner compensation must be included in the budget โ€” PCORI expects patient partners to be paid for their time at appropriate rates

Eligibility Requirements

  • U.S. registered nonprofit or for-profit organizations, academic institutions, health systems, or government entities
  • Principal Investigators must have sufficient research experience and institutional support
  • No requirement for prior PCORI funding โ€” but Pipeline to Proposal awards specifically target new applicants
  • Multi-site studies encouraged โ€” PCORI favors research conducted across diverse health care settings and patient populations
  • Studies must focus on comparative effectiveness โ€” not efficacy studies comparing treatment to placebo

How to Apply

  • Step 1 โ€” Review current PCORI funding announcements: All open funding announcements are at pcori.org/funding. Each announcement includes specific focus areas, eligibility, and review criteria. PCORI publishes a research agenda โ€” proposals that align with stated priorities score higher.
  • Step 2 โ€” Attend a Funding Opportunity Webinar: PCORI hosts mandatory or strongly recommended webinars for each funding opportunity. These cover requirements, common errors, and reviewer expectations โ€” attend before writing the proposal.
  • Step 3 โ€” Submit a Letter of Intent (LOI): Most PCORI opportunities require an LOI before full application. The LOI (2โ€“3 pages) describes the research question, study design, and team. PCORI provides feedback on LOIs before full submissions are invited.
  • Step 4 โ€” Prepare the full application: Core sections: Research Plan (including population, comparators, outcomes, study design, analysis plan), Patient and Stakeholder Engagement Plan, Dissemination and Implementation Plan, Budget and Justification, Team Qualifications.
  • Step 5 โ€” Submit through PCORI's Online System: PCORI uses its own submission portal โ€” not Grants.gov. Register at pcori.org well in advance of the deadline.

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โ—†
ClinicalMetric Research Team
Clinical Trial Research & Analysis
Analysis compiled from ClinicalTrials.gov (NIH/NLM), FDA trial registry data, and peer-reviewed clinical research. ClinicalMetric tracks 400,000+ active clinical trials worldwide, updated daily from the ClinicalTrials.gov AACT database.
โ—†
ClinicalMetric Intelligence Team
Clinical Trial Research & Analysis ยท Last updated April 2026
Analysis compiled from ClinicalTrials.gov (NIH/NLM), FDA trial registry data, and peer-reviewed clinical research. ClinicalMetric tracks 400,000+ active clinical trials worldwide, updated daily from the ClinicalTrials.gov AACT database.
Get Weekly Clinical Trial Alerts
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โ—† Clinical Trial Intelligence at a Glance
400K+
Active trials tracked
200+
Countries with active trials
4
Clinical trial phases
Daily
Data refresh from ClinicalTrials.gov
โ—† Clinical Trial Phase Transition Success Rates
Phase 1 โ†’ Phase 2 success ~63%
Phase 2 โ†’ Phase 3 success ~32%
Phase 3 โ†’ Approval ~58%
Overall FDA approval rate ~12%
Source: Biotechnology Innovation Organization (BIO) Clinical Development Success Rates โ€” approximate industry averages.
โ—† Clinical Trial Development Timeline
Mo 1โ€“6
Preclinical + IND Filing
Mo 6โ€“18
Phase 1 (Safety)
Mo 18โ€“48
Phase 2 (Efficacy)
Mo 48โ€“84
Phase 3 (Pivotal)
Mo 84โ€“96
FDA Review / NDA
Mo 96+
Approval + Phase 4
Timeline is approximate. Total development from preclinical to approval averages 6โ€“13 years.
โ—†
About the Author
ClinicalMetric Research Team
Clinical Trial Intelligence Specialists ยท clinicalmetric.com
Our analysts monitor 400,000+ clinical trials daily across oncology, neurology, cardiology, and rare diseases. All data sourced from ClinicalTrials.gov and FDA.gov.
๐Ÿ”ฌ 400K+ trials tracked ๐ŸŒ 200+ countries ๐Ÿ”„ Updated: April 2026
โ—† Common Questions About Clinical Trials
What is a clinical trial? +
A clinical trial is a research study involving human participants designed to evaluate medical interventions โ€” such as drugs, devices, or behavioral strategies. Trials follow a structured protocol and are registered on ClinicalTrials.gov. They progress through phases: Phase 1 (safety), Phase 2 (efficacy), Phase 3 (large-scale comparison), and Phase 4 (post-market surveillance).
How do I find clinical trials I'm eligible for? +
You can search ClinicalTrials.gov or use ClinicalMetric to filter by condition, phase, or location. Each trial listing includes eligibility criteria such as age range, sex, diagnosis, and prior treatment history. Contact the study team directly or ask your physician to refer you to a relevant trial.
Are clinical trials safe to participate in? +
Clinical trials are conducted under strict ethical and regulatory oversight, including IRB approval and FDA regulation in the US. All participants must give informed consent after reviewing potential risks and benefits. Phase 1 trials carry more uncertainty, while Phase 3 trials involve interventions with an established safety profile. Participation is always voluntary and you may withdraw at any time.
What are the phases of clinical trials? +
Clinical trials progress through four main phases. Phase 1 tests safety and dosing in a small group (20โ€“80 people). Phase 2 evaluates efficacy and side effects in a larger group (100โ€“300). Phase 3 compares the intervention against standard treatments in thousands of participants. Phase 4 occurs after approval and monitors long-term effects in the general population.
Do participants get paid for joining clinical trials? +
Many clinical trials offer compensation for time and travel expenses, though payment structures vary widely by study. Compensation is not intended to be coercive. Some trials also cover treatment costs for participants. Always review the consent form carefully and ask the study coordinator about any financial considerations before enrolling.
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ClinicalMetric โ€” Independent clinical trial intelligence platform. Not affiliated with NIH, ClinicalTrials.gov, the U.S. FDA, or any pharmaceutical company, hospital, or clinical research organization. Trial data is sourced from ClinicalTrials.gov for informational purposes only and does not constitute medical advice. Do not make any treatment, enrollment, or health decisions based solely on information found here โ€” always consult a qualified healthcare professional. Full Disclaimer  ยท  Last Reviewed: April 2026  ยท  Data Methodology