CFAs: Phased Large Awards for Comparative Effectiveness Research (US)

The goal of the Phased Large Awards for Comparative Effectiveness Research (PLACER) PCORI funding announcement (PFA) is to support large-scale, high-impact randomized trials in patient centered comparative clinical effectiveness research (CER) whose risk in achieving their research aims merits an initial period of testing and refinement to determine their feasibility and viability and to maximize the likelihood of full-scale trial success.

PCORI seeks funding applications for large, randomized trials in patient-centered clinical CER that are structured into two well-integrated phases: an initial feasibility and testing phase (to establish the trial design, operations, infrastructure, analysis, and the ability to enroll and randomize participants) followed by a second phase in which conduct of the full-scale clinical trial proceeds based on successful accomplishment of groundwork completed in the feasibility phase.

Priorities

• This funding opportunity seeks applications that address three of PCORI’s National Priorities for Health. To be considered responsive, applications must propose research that meets this PFA’S distinctive requirements and addresses at least one of the following National Priorities for Health:
  • Increase Evidence for Existing Interventions and Emerging Innovations in Health: Strengthen and expand ongoing CER 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: 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: Expand stakeholder engagement, research, and dissemination approaches that lead to continued progress toward achieving health equity in the United States.

Funding Information

• Funds Available: up to approximately $200 million
• Maximum Project Budget: $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)

Eligible Activities

• Activities captured in milestones include but are not limited to the following:
  • Developing a study protocol and procedure manual for the intervention
  • Assigning roles and responsibilities to study team members for project implementation
  • Developing and structuring partnerships with stakeholders
  • Preparing research team members, patients, and stakeholders to collaborate effectively
  • Providing a detailed task-based budget with level of effort for project staff, specified by task
  • Obtaining clearances from all institutional and community partners, including institutional review board approvals
  • Establishing a DSMB or providing a clear description to justify why one is unnecessary.

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.
• Foreign organizations and nondomestic components of U.S. organizations must provide a thorough and thoughtful justification for the research’s ability to benefit the U.S. healthcare system and that the engagement plans include U.S. patients and stakeholders and are relevant to the U.S. healthcare system.

Ineligibility Criteria

• Individuals are not permitted to apply.

Review Criteria

• Potential for the study to fill critical gaps in evidence
• Potential for the study findings to be adopted into clinical practice and improve delivery of care
• Scientific merit (research design, analysis, and outcomes)
• Investigator(s) and environment
• Patient centeredness
• Patient and stakeholder engagement.

For more information, visit PCORI.