Funding available for Comparative Effectiveness Research – United States

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. The initial period of testing, termed the feasibility phase, requires robust and diverse stakeholder input and engagement to assess equipoise among study participants (such as health systems, clinicians, and patients) and thus maximize their participation in the research study. As appropriate and necessary, the feasibility phase allows for refinement of the research question, outcomes, data collection methods, and data instruments. The feasibility phase is expected to include empiric testing of recruitment and enrollment assumptions and the feasibility of study conduct to detect and address unanticipated challenges to study execution before a full-scale study is implemented. Statistical rigor and power are likewise strengthened by using the feasibility phase to work collaboratively with the expertise of a Data Coordinating Center (DCC) to refine data management, statistical analyses, and Data Safety Monitoring Board/Data Monitoring Committee support.

Priorities

• This funding opportunity seeks applications addressing one or more of three of PCORI’s National Priorities for Health as shown below. 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.
  • Achieve Health Equity
    • Goal: Expand stakeholder engagement, research and dissemination approaches that lead to continued progress toward achieving health equity in the United States.
  • 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.

Themes

• The Topic Themes, clustered into three groups, are as follows:
  • Populations
    • Improving outcomes for people with intellectual and developmental disabilities (IDD)
    • Promoting health for older adults
    • Promoting healthy children and youth
  • Health Behaviors
    • Addressing substance use
    • Addressing violence and trauma
  • Health Conditions
    • Addressing COVID-19
    • Addressing rare diseases
    • Improving cardiovascular health
    • Improving mental and behavioral health
    • Managing pain
    • Preventing maternal morbidity and mortality (MMM)
    • Promoting sleep health

Funding Information

• Maximum: $22 million (Feasibility phase maximum: $2 million; Full-scale study phase: $20 million)
• The feasibility phase should be completed no later than 18 months after contract initiation, and the subsequent phase involving full-scale study conduct should not exceed five years.

Research Requirements

• To be considered responsive, applications must do the following:
  • Describe comparators. Regardless of the approach being studied, all proposed research projects must compare at least two alternatives. If the applicant proposes usual care as a rational and important comparator in the proposed study, then it must be described in detail, coherent as a clinical alternative, and properly justified as a legitimate comparator.
  • Describe research that compares two or more alternatives, each of which has established evidence of efficacy and current use in multiple settings. If efficacy is not well established, then widespread use must be well documented. PCORI expects the efficacy or effectiveness of each intervention to be well characterized. The application must provide robust evidence of the efficacy of the interventions that will be compared; peer-reviewed publication of efficacy data from substantive pilot data may be deemed appropriate.
  • Describe research that studies the benefits and harms of interventions and strategies delivered in real-world settings. PCORI is interested in studies that provide practical information that can help typical patients, care settings, and diverse stakeholders make informed decisions about their choices and likely outcomes of healthcare options.
  • Describe engagement with patients and members of the broader health and healthcare community about how the study is answering a critical question. PCORI expects applicants to explain the pertinent evidence gaps and why the project question or questions represent decisional dilemmas for patients, caregivers, clinicians, policy makers, and other healthcare system stakeholders.
  • Provide complete and replicable statistical analyses. The proposed research should be supported by robust statistical analyses that are described in sufficient detail to allow for independent statistical confirmation of the proposed assumptions, statistical power, and study sample size.

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.

Ineligibility Criteria

• Individuals are not permitted to apply.

For more information, visit PCORI.