Retrospective Observational Studies

New Patient-Centered Outcomes Research Institute (PCORI) funding opportunity. Up to $2 million in direct costs for retrospective observational studies.  The studies should be in comparative clinical effectiveness research (CER), comparing two or more approaches for prevention, diagnosis, treatment, or care delivery.  The studies must leverage existing data sources and infrastructure ready for patient-centered CER, including but not limited to PCORnet®, the National Patient-Centered Clinical Research Network. The research project can have a duration of up to 18 months.

Studies should:

  • Compare existing interventions that have robust evidence of efficacy or are currently in widespread use
  • Include evidence-based, impactful, patient-centered outcomes as indicated by patients, families, and caregivers (particularly those with lived experience) from the population of interest, as well as relevant members of the broader health and healthcare community
  • Examine diverse populations 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

All proposed applications must respond to at least one of the following topic themes:

  • Addressing cancer
  • Improving outcomes for people with intellectual and developmental disabilities
  • Preventing maternal morbidity and mortality
  • Improving mental and behavioral health
  • Improving metabolic and endocrine health
  • Managing pain
  • Addressing rare diseases
  • Addressing sensory health
  • Addressing substance use

Highlights

  • Up to $25 million in total available funding
  • Up to $2 million direct costs available per application
  • Maximum project period: 18 months
  • December 2 – Application opens
  • December 10 – Town Hall
  • January 6, 2026 – Letters of Intent due

How to Apply

To apply for this funding opportunity, there are four steps you must follow.

  • Read the full funding announcement, available online.
  • Follow the process outlined in the submission instructions.
  • Submit a Letter of Intent using the template on the application page.
  • Submit an application (if invited).

Important Dates

December 2 – Applications open
December 10 – Town Hall
January 6, 2026 – Letters of Intent due
February 3, 2026 – LOI status notification
May 5, 2026 – Applications due
July 2026 – Merit review
November 2026 – Awards announced
March 2027 – Earliest start date

Harvard Catalyst PCORI Consultation

For more information or to request a brief consultation, please contact Leslie MacGregor, PCORI Funding Specialist: Leslie_MacGregor@hms.harvard.edu