Comparative Clinical Effectiveness Research Funding to Improve Patient-Centered Outcomes (US)

Applicants are encouraged to propose long-term follow-up studies of PCORI-funded clinical trials or observational studies Proposed studies should examine large and diverse populations with an overall sample size that will allow for precision in the estimation of hypothesized effect sizes and, as appropriate, analysis of heterogeneity of treatment effects. Applicants are encouraged to pay special attention to issues of intervention implementation with an aim to facilitate widespread uptake of findings after study completion. However, strict implementation or dissemination studies or studies focused on the development of research methods will not be considered responsive.

Priorities

• To be considered responsive, applicants 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
    • Goal: 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
    • Goal: Foster actionable, timely, place-based, and transformative improvements in patient-centered experiences, care provision, and 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.
  • Advance the Science of Dissemination, Implementation, and Health Communication
    • Goal: Advance the scientific evidence for and the practice of dissemination, implementation, and health communication to accelerate the effective sharing of CER results for public understanding and uptake into practice.

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

• Up to $5 million
• At the time of contract execution, PCORI sets aside all the funds associated with an awarded project to be made available throughout the contract’s period of performance. The maximum budget includes all research- and peer-review-related costs.
• Duration
  • Up to 5 years
  • The research project period proposed for the research project should be commensurate with the effort required to complete the project but cannot exceed 5 years. This PFA does not consider exceptions to the maximum research project period. PCORI will not review submissions exceeding the stated maximum research project period.

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 efficacy and/or is in widespread use. PCORI expects the efficacy or effectiveness of each intervention to be known. If the efficacy or evidence base is insufficient, then data must be provided to document that the intervention is used widely. The application must provide information about the efficacy of the interventions that will be compared; pilot data might be appropriate. Projects aiming to develop new interventions that lack evidence of efficacy, effectiveness, or widespread use will be considered out of scope.
  • 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 patients and members of the broader health and healthcare community make informed decisions about their health care and health outcomes.
  • Describe consultation 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 questions represent decisional dilemmas for patients, caregivers, clinicians, policy makers, and other healthcare system stakeholders. Describe why project outcomes are especially relevant and meaningful endpoints to patients and members of the broader health and healthcare community.

Eligibility Criteria

• This competition is limited to currently active PCORI CER awardees, in their second contract year or later, who meet the following eligibility criteria:
  • Have a Contract Start (Effective) Date in June 2023, or earlier, and a Contract Term (End) Date in June 2024, or later.
  • Are in good scientific, operational, and financial standing. Metrics for assessment include, but are not limited to, overall study progress as evidenced by timely milestone completion, satisfactory data completeness and quality, and acceptable participant enrollment and retention (if applicable).
• 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.