Introduction

PCORI’s mission is to produce knowledge that allows individuals to make informed health care decisions and that improves health care delivery and outcomes. One of our National Priorities for Health, Achieve Health Equity, recognizes that for some patients and caregivers the information and knowledge needed to make an informed decision is not available because of the historical lack of diversity in research study participants. Diverse study populations also increase the impact of project results and increase our ability to analyze heterogeneity of treatment effects in diverse groups.

PCORI seeks investigator-initiated requests to build on existing, PCORI-funded comparative clinical effectiveness research (CER) studies to increase the diversity and representativeness of study populations, and/or otherwise augment the project to increase impact on one of PCORI’S National Priorities for Health: Achieve Health Equity. Awardees must leverage meaningful engagement of affected/relevant communities to ensure that a diverse and inclusive study population can be achieved.

Only PCORI-funded principal investigators/institutions with active CER project funding contracts are eligible to submit a request in response to this opportunity.

Purpose

The aim of this supplemental funding opportunity is to produce knowledge to advance health equity. This may include (but is not limited to) the following approaches:

1. The addition of sites, recruitment methods and/or strategies that enhance the diversity of study samples
2. An increase in the sample size to increase diversity/representativeness and add or enhance heterogeneity of treatment effect analyses. Increases in sample size must focus on increasing the study population diversity rather than simply increasing the overall number of participants. Requests that add sites without a specific focus on enhancing diversity will be considered unresponsive.

Awardees are expected to utilize enhanced engagement practices to ensure that a diverse and inclusive study population is achieved.

Eligibility

• Awarded contracts that were funded under PCORI Funding Announcements (PFAs) issued in Cycle 1 2021 or later.
• Projects must have submitted at least one Interim Progress Report (IPR) by June 1, 2023, and have the Final Progress Report (FPR) due on October 1, 2024, or later.
• Project is deemed by PCORI staff to be in good standing. Metrics for assessment include:
  • On-time completion of project milestones to date.
  • Cumulative enrollment progress (if the project includes prospective enrollment of participants and is anticipated to have started enrollment by the Supplement application receipt date).
• Project has not received a cumulative extension of greater than 18 months to the original executed contract’s research period of performance end date (i.e., the FPR due date).
• Phased Large Awards for Comparative Effectiveness Research (PLACER) awards currently in the Feasibility Phase are not eligible.
• Eligible awardees may apply for either this supplemental funding opportunity or the Supplemental Funding for Existing PCORI-funded Comparative Clinical Effectiveness Research to Improve Understanding of Patient-Centered Economic Outcomes opportunity, not both.
• Awardees that received a prior award under the PCORI COVID-19 enhancement mechanism are eligible to apply.

Specifications

Supplements for all projects should seek to leverage existing project personnel expertise and infrastructure when possible. Additional personnel may be necessary to ensure there is appropriate expertise on the research team and/or additional support for stakeholders or community-based organizations may be necessary to enable enhanced outreach in the community. Requests for supplement funding should provide evidence that existing project stakeholders support the proposed supplement and should include an enhanced engagement plan. Proposed supplements must adhere to the PCORI Methodology Standards. A detailed report of all work completed as part of the supplement will be included in the original award’s Draft Final Research Report (DFRR).

Review and Approval Process

Following submission, PCORI will complete review of each request. You may be contacted by your assigned Program Officer (PO) for additional information as part of PCORI’s review.

Determinations for Supplement funding will be made using the review criteria below:

1. Demonstrated impact on participant diversity and/or potential to meaningfully advance health equity
2. Methodological rigor: e.g., if heterogeneity of treatment effect analyses are proposed, they must be adequately powered to assess diverse subgroups of the population
3. Appropriate expertise on the research team to enhance diversity and/or conduct health-equity-related research, and/or demonstrated interest or partnership from new collaborators or sites, as applicable
4. Appropriate enhanced engagement practices, as informed by the local community
5. Requested budget amount commensurate with scope of proposed supplement
6. Feasibility of adding the proposed supplement to the current study
7. Currently funded award is in good standing and no anticipated negative impact of the supplement on success of the original award

Key Dates