Phased Large Awards for Comparative Effectiveness Research – Cycle 2 (US)

Deadline: 31-May-23

The PCORI Funding Announcement (PFA) invites applications for high-quality comparative clinical effectiveness research (CER) projects that will address critical decisions faced by patients, caregivers, clinicians, and stakeholders across the health and healthcare community and for which there is insufficient evidence.

Investigators must propose an individual-level or cluster randomized controlled trial of significant scale and scope for this PFA. The proposed trials should address critical decisional dilemmas that require important new evidence about the comparative clinical effectiveness of available interventions. Proposed studies should compare interventions that already have robust evidence of efficacy and are in current use. If efficacy is not well-established, then widespread use must be documented. Clinical interventions (such as medications, diagnostic tests, or procedures) and delivery system interventions (such as workforce, technologies, and healthcare service delivery designs) are appropriate for these studies.

This funding opportunity seeks applications addressing three of PCORI’s National Priorities for Health. To be considered responsive, applications must propose research meeting the distinctive requirements of this PFA and address at least one of the following National Priorities for Health:

• Increase Evidence for Existing Interventions and Emerging Innovations in Health
  • Goal: Strengthen and expand ongoing comparative clinical effectiveness research focused on both existing interventions and emerging innovations to improve healthcare practice, health outcomes, and health equity.
• Accelerate Progress Toward an Integrated Learning Health System
  • Goal: Foster actionable, timely, place-based, and transformative improvements in patient-centered experiences, care provision, and ultimately improved health outcomes through collaborative, multisectoral research to support a health system that understands and serves the needs and preferences of individuals.
• Achieve Health Equity
  • Goal: Expand stakeholder engagement, research, and dissemination approaches that lead to continued progress toward achieving health equity in the United States.

Funding Information

• $22 million (Feasibility phase maximum: $2 million; Full-scale study phase: $20 million)
• Maximum Research Project Period 6.5 years (Feasibility phase: 1.5 years; Full-scale study phase: 5 years)

Eligibility Criteria

• In general, applications for the conduct of research and management of funding may be submitted by appropriate academic research, private sector research, or study-conducting entities. This may include, among others, agencies and instrumentalities of the Federal
• Government, nonprofit and for-profit research organizations, and colleges and universities.
• Per PCORI’s authorizing statute, every applicant must demonstrate capability to comply with the following conditions:
  • abide by the transparency and conflicts of interest requirements that apply to PCORI with respect to the research managed or conducted under contract;
  • comply with the PCORI methodological standards adopted by the Board of Governors;
  • consult, as appropriate, with the expert advisory panels for clinical trials and rare disease;
  • deposit de-identified data from the original research into a PCORI-designated repository to facilitate data sharing, as appropriate;
  • have appropriate processes in place to manage data privacy and meet ethical standards for the research;
  • comply with the requirements of PCORI for making the information available to the public; and
  • comply with other terms and conditions determined necessary by PCORI to carry out the research project.
• Potential applicants are strongly encouraged to review the standard research contract prior to application.

Ineligible

• Individuals are not permitted to apply.
• Foreign Organizations and Nondomestic Components of U.S. Organizations must provide a thorough and thoughtful justification for the research’s ability to benefit the US healthcare system and that the engagement plans include US patients and stakeholders, and are relevant to US healthcare system.

For more information, visit PCORI.