Applications Open for Broad Pragmatic Studies Funding Program (United States)

The Broad Pragmatic Studies PCORI Funding Announcement provides funding of up to $12 million in direct costs for high-impact patient-centered comparative clinical effectiveness research (CER) projects. The program supports studies that improve healthcare decision-making through meaningful patient engagement, rigorous research methods, and evidence that can be applied in real-world healthcare settings.

About the Broad Pragmatic Studies PCORI Funding Announcement

The Patient-Centered Outcomes Research Institute (PCORI) is inviting applications under its Broad Pragmatic Studies Funding Announcement to support large-scale, high-impact patient-centered comparative clinical effectiveness research (CER).

The funding opportunity aims to generate practical evidence that helps patients, caregivers, clinicians, and healthcare systems make informed healthcare decisions. Supported projects should compare existing healthcare interventions, treatments, or care strategies and evaluate which approaches work best for different patient populations in real-world settings.

The program encourages strong collaboration between researchers, patients, caregivers, healthcare providers, and community partners throughout the research process.

Program Objectives

The funding opportunity aims to:

• Advance patient-centered comparative clinical effectiveness research.
• Generate evidence that improves healthcare decisions.
• Compare existing interventions, treatments, and care strategies.
• Improve health outcomes across diverse patient populations.
• Promote meaningful patient and stakeholder engagement.
• Support implementation of research findings into healthcare practice.
• Strengthen evidence-based healthcare delivery.

Research Priority Areas

Projects should align with PCORI’s Research Project Agenda and Topic Themes, including:

• Mental health outcomes for pregnant and postpartum populations.
• Substance use prevention and treatment.
• Cancer survivorship.
• Diabetes prevention, treatment, and long-term management.
• Neuropathic pain management.
• Pain management for individuals with intellectual and developmental disabilities.
• Pain management for people living with Alzheimer’s disease and related dementias.

Types of Research Supported

PCORI encourages several research approaches, including:

• Randomized Controlled Trials (RCTs).
• Pragmatic clinical trials.
• Observational comparative effectiveness studies.
• Natural experiments.
• Real-world evidence studies.
• National-scale research using healthcare data networks.
• Studies focused on patient-centered outcomes.

Projects should generate evidence that can be applied directly in routine healthcare practice.

Funding Information

The funding opportunity offers three categories of support:

Category 1

• Up to $5 million in direct costs.
• Project duration of up to 5 years.

Category 2

• Up to $12 million in direct costs.
• Up to 5 years of funding.
• Applicants must justify the larger budget and expanded project scope.

Category 3

• Up to $12 million in direct costs.
• Up to 5 years.
• Must utilize PCORnet for national-scale observational studies or pragmatic clinical trials.

Additional support may include:

• Patient care costs (subject to approval).
• Structured mentorship activities.
• Research implementation support.

Who is Eligible?

Eligible applicants must:

• Propose patient-centered comparative clinical effectiveness research.
• Include meaningful engagement of patients and research partners throughout the project.
• Use scientifically rigorous study designs.
• Employ validated outcome measures.
• Include sufficient sample sizes to estimate expected treatment effects.

Additional Requirements for Category 3

Applicants must:

• Use PCORnet.
• Include two or more Clinical Research Networks.
• Conduct national-scale observational studies or pragmatic trials.
• Share study progress and performance data with the network.

Eligible Research Designs

Applicants may use:

• Randomized clinical trials.
• Pragmatic trials.
• Comparative observational studies.
• Natural experiments.
• Hybrid effectiveness-implementation studies.

The selected design should appropriately address the proposed research question while maintaining scientific rigor.

Why This Funding Matters

This funding opportunity helps generate evidence that directly improves healthcare decision-making.

The program is important because it:

• Produces real-world evidence for patients and clinicians.
• Encourages patient participation throughout research.
• Supports implementation of research findings.
• Addresses major healthcare challenges.
• Improves health outcomes across diverse populations.
• Promotes evidence-based healthcare policy and practice.

Application Process

Applicants must complete the following steps:

1. Develop a patient-centered comparative effectiveness research proposal.
2. Build partnerships with patients, caregivers, clinicians, and other stakeholders.
3. Select the appropriate funding category.
4. Submit a Letter of Intent (LOI) through PCORI Connect.
5. Await invitation from PCORI.
6. Submit the full application if invited.
7. Participate in PCORI’s merit review process.
8. Complete award negotiations if selected.

Application Requirements

Applications should include:

• Clearly defined research objectives.
• Comparative effectiveness research design.
• Patient engagement strategy.
• Appropriate statistical analysis plan.
• Validated outcome measures.
• Budget justification.
• Timeline and milestones.
• Dissemination and implementation strategy.
• Required supporting documentation.

Selection Criteria

Applications will be evaluated based on:

• Scientific quality.
• Patient-centeredness.
• Comparative effectiveness relevance.
• Stakeholder engagement.
• Study feasibility.
• Research methodology.
• Expected healthcare impact.
• Budget appropriateness.
• Implementation potential.

Category 2 proposals require additional justification for larger budgets.

Category 3 proposals will also be evaluated on their use of PCORnet and collaboration across Clinical Research Networks.

Tips for Applicants

To improve your application:

• Engage patients and stakeholders from project planning through dissemination.
• Select outcomes that are meaningful to patients.
• Clearly explain how the study will improve healthcare decisions.
• Use rigorous and appropriate study methods.
• Provide realistic timelines and budgets.
• Demonstrate strong collaboration among research partners.
• Ensure alignment with PCORI research priorities.

Common Mistakes to Avoid

Avoid the following:

• Limited patient or stakeholder engagement.
• Weak comparative effectiveness research design.
• Poorly justified budgets.
• Unclear research objectives.
• Inadequate outcome measures.
• Insufficient statistical power.
• Missing implementation or dissemination plans.
• Failure to meet Category 3 network requirements where applicable.

Frequently Asked Questions (FAQs)

Who can apply for the Broad Pragmatic Studies PCORI Funding Announcement?

Organizations proposing patient-centered comparative clinical effectiveness research that meets PCORI requirements may apply.

What is the maximum funding available?

Category 1 provides up to $5 million in direct costs, while Categories 2 and 3 provide up to $12 million in direct costs.

How long can projects last?

Projects may receive funding for up to five years.

Is a Letter of Intent required?

Yes. Applicants must submit a Letter of Intent (LOI) through PCORI Connect before submitting a full proposal.

Can applicants submit a full proposal without an invitation?

No. Full applications may only be submitted after receiving an invitation from PCORI.

What research designs are encouraged?

PCORI encourages randomized controlled trials, pragmatic clinical trials, observational comparative effectiveness studies, and natural experiments.

What is required for Category 3 projects?

Category 3 projects must use PCORnet, involve at least two Clinical Research Networks, conduct national-scale studies, and share study progress and performance information with the network.

Conclusion

The Broad Pragmatic Studies PCORI Funding Announcement offers a significant opportunity for organizations conducting patient-centered comparative clinical effectiveness research. With funding of up to $12 million, support for projects lasting up to five years, and an emphasis on meaningful patient engagement, the program seeks to generate high-quality evidence that improves healthcare decisions, strengthens clinical practice, and delivers better outcomes for patients across the United States.