Applications open for PCORI Funding for Broad Pragmatic Studies (US)

PCORI invites applications addressing patient-centered CER questions that meet the scope and intent of this PFA and align with four of PCORI’s National Priorities for Health. The remaining National Priority, Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research, is covered by other PCORI funding opportunities.

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.
• Applicants will be asked to select one of these four National Priorities as primary, and if relevant, a secondary and/or tertiary National Priority in their Letter of Intent (LOI) and, if invited, full application.

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

Categories & Funding Information

• PCORI will commit up to $160 million per cycle through this funding opportunity. The BPS PFA will offer three categories based on award size and requirements. All applications, regardless of category, must align the proposed research with at least one of the four National Priorities for Health described within the PFA.
• Category 1
  • Category 1 will support research projects with direct costs up to and including $5 million.
• Category 2
  • Category 2 will support research projects with direct costs greater than $5 million and up to a maximum of $12 million. Applications for funding under Category 2 will be expected to justify the proposed research’s size and scope and why additional funds are necessary to support the scale, scope and complexity of personnel and material resources needed to address the research question.
• Category 3
  • Category 3 will support research projects with direct costs up to $12 million that utilize PCORnet® to conduct observational studies and/or pragmatic trials that are national in scale. Category 3 PCORnet Studies® must include two or more Clinical Research Networks and share study progress, performance metrics and best practices with the network to promote continuous learning and improvement. PCORnet Studies will leverage the PCORnet Common Data Model® as appropriate.

Special Areas of Emphasis

• For Cycle 2 2024, PCORI has identified Special Areas of Emphasis (SAEs) within the BPS funding opportunity to support innovative, high-impact studies that fit clearly within our core mission of patient-engaged and patient-centered CER.
• The purpose of calling out these SAEs is to encourage submissions to these areas, not to limit submissions to these topics. Applicants addressing an SAE must identify which of the listed areas of research is best associated with their research approach.
  • Post-Traumatic Stress Disorder: PCORI is interested in supporting research to test the comparative clinical effectiveness of treatment options for post-traumatic stress disorder (PTSD). Of particular interest are studies including children and youth, veterans and civilian adults with varying types of trauma. Studies focused on comparing strategies to enhance delivery of PTSD care outside of specialty mental health settings and advancing health equity are especially encouraged.
  • Improving Health and Quality of Life in Down Syndrome: People with Down syndrome are more likely to experience co-occurring conditions like obesity and cardiovascular disease, although there is a lack of evidence on whether treatment approaches developed for the general population are also effective in individuals with Down syndrome. PCORI is interested in comparing interventions to improve the health and well-being of individuals with Down syndrome, particularly in approaches addressing mental health/well-being, cardiovascular disease, obesity, diabetes, obstructive sleep apnea and Alzheimer’s disease. Research can be conducted in clinical or community settings, and interventions can be at the individual and/or system level.
  • Peripheral Arterial Disease: PCORI is interested in supporting research in diagnostic and therapeutic options for patients with either intermittent claudication and/or critical limb ischemia. Although submissions are not limited to these topics, areas of interest to PCORI include reducing disparities in care, systems-level comparisons for optimal treatment, direct comparisons of non-surgical treatment options, comparisons of screening approaches and options to promote long term treatment adherence.
  • Functional Sensory Impairment in Older Adults: PCORI is interested in patient-centered CER projects focused on older adults who experience sensory impairments associated with aging — more specifically, hearing or visual impairment. Areas of interest include studies proposing to compare different screening and follow-up strategies to promote early detection and management strategies, both of which address important decisional dilemmas faced by patients and their caregivers. Interventions in diverse healthcare settings and within underserved populations experiencing disparities in both access and in outcomes are also especially encouraged.

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

• 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.