Notice of Upcoming PCORI Funding Announcement

Key Dates

  • PFA Opens
    May 7, 2024
  • Applicant Town Hall
    May 9, 2024; 12 pm (ET)
  • Letter of Intent (LOI) Deadline
    June 4, 2024; 5 pm (ET)
  • LOI Status Notification
    July 2, 2024
  • Application Deadline
    Sept. 4, 2024; 5 pm (ET)

The Patient-Centered Outcomes Research Institute (PCORI) intends to issue a limited competition PCORI Funding Announcement (PFA) on May 7, 2024, to fund high-quality patient-centered comparative clinical effectiveness research (CER) projects focusing on long-term follow-up of patient-centered outcomes. This funding opportunity is limited to currently active PCORI CER awards. This preannouncement provides potential applicants additional time to identify collaborators; obtain patient and stakeholder input on potential long-term questions; and develop responsive, high-quality proposals.

Eligibility

Only PCORI-funded principal investigators/institutions with active CER contracts are eligible to submit a letter of intent in response to this opportunity. Awarded CER contracts funding randomized controlled trials or observational studies are eligible to apply.

Awarded contracts must:

  • Be in the second contract year or later (i.e., more than one year from the contract start date).
  • Be 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/retention (if applicable).

Research Initiative Highlights

Health interventions often have long-term effects, and their impact can appear years after first exposure. Long-term follow-up allows the opportunity to examine later effects of therapeutic interventions, treatments and programs providing a more comprehensive view of intervention benefits and harms. This PCORI Funding Announcement will solicit applications that focus on long-term follow-up of current PCORI-funded patient-centered CER awards aiming to:

1. Answer the previously defined CER question with a longer time horizon by extending follow-up of the previously specified primary and secondary outcomes. Examples include studies that propose to:

  • Assess whether observed differences change over time (e.g., early benefits are sustained).
  • Assess the persistent impact of study interventions (e.g., behavioral change in obesity or treatment adherence/retention in substance use studies) after the initial research period.

2. Answer a new CER question related to the interventions being compared by adding new primary/secondary outcomes that require a longer time horizon. Examples include studies that propose to:

  • Assess additional clinical outcomes that would be detectable with sufficient statistical power resulting from longer patient follow-up.
  • Assess longer-term safety risks that may be unrecognized or underestimated with shorter durations of follow-up. 
  • Assess patient-centered outcomes in special populations (e.g., examining offspring outcomes after peripartum interventions).

Studies proposing the continuation of ongoing/periodic interventions (e.g., annual screening) will be required to provide supportive data from the original study to demonstrate continued clinical equipoise. Studies that propose a new intervention will not be considered responsive.

Applicants should propose well-justified long-term outcomes that are clinically meaningful and considered important by patients and other stakeholders. Applicants must demonstrate a clearly specified causal/intervention logic model that the proposed long-term outcomes are plausibly relatable to the intervention for the period of proposed follow-up. Applicants should consider, as appropriate, the full range of long-term clinical and patient-centered outcomes data relevant to patients and other stakeholders. PCORI’s Principles for the Consideration of the Full Range of Outcomes Data in PCORI-Funded Research inform the expectations for applicants and the corresponding evaluation of applications submitted in response to this PFA.

Proposed studies should examine a sufficient and representative sample of the original study population with an overall sample size that will allow precision in the estimation of hypothesized effect sizes and, as appropriate, analysis of heterogeneity of treatment effect for the proposed long-term outcomes. All participants required for the long-term follow-up study must be enrolled during the original study. Studies proposing enrollment of additional participants into the follow-up study will not be considered responsive. Applicants should demonstrate that informed consent mechanisms are set up to acquire follow-up data in the long term and minimize or avoid the need to re-consent participants. Applicants will be required to submit data from their existing PCORI award as part of their application to support their ability to retain participants for long-term follow-up.

Applicants are encouraged to capitalize on the availability of linkable electronic health record data, if appropriate, and leverage existing project personnel expertise and infrastructure when possible. At least one core member of the research team must have demonstrated experience with long-term follow-up studies.

PCORI is particularly interested in applications that have relevance to PCORI’s Topic Themes, but applications are not limited to these areas. Applicants are encouraged to pay special attention to issues of intervention implementation with an aim of facilitating widespread uptake of findings after completion of the study. However, strict implementation or dissemination studies will not be considered responsive, nor will studies focused on the development of research methods.

This funding announcement will accept applications with direct costs up to $5 million and up to five years in duration. For this funding announcement, applicants are not permitted to request PCORI coverage of patient care costs (including medical products, procedures and care services) to extend the intervention.

Please contact PCORI ([email protected]) to schedule a consultation. For additional information, please see the full announcement upon posting.

Key Dates

Online System Opens
May 7, 2024
Applicant Town Hall
-
View Event
Letter of Intent Deadline
June 4, 2024, 5 pm (ET)
Letter of Intent Status Notification
July 2, 2024
Application Deadline
Sept. 4, 2024, 5 pm (ET)
Merit Review
November 2024
Awards Announced
April 2025
Earliest Start Date
August 2025

Funds and Project Period

Funds Available Up To
$50 million
Total Direct Costs
Up to $5 million
Maximum Project Period
Up to five years

Tags

Year
Award Types
Cycle
Status