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HCN Grants Est. 2026
No. PAR-25-450 · National Institutes of Health
Open

Clinical Trial Readiness for Rare Diseases, Disorders, and Syndromes (R21 Clinical Trial Not Allowed)

Dealbreakers No cost share required Audit: not stated Reimbursement-only: not stated

At a glance

This program funds clinical projects that improve readiness for future clinical trials in rare diseases by validating biomarkers or clinical outcome measures, or by defining disease natural history and patient characteristics needed for trial design. It does not fund clinical trials, biomarker discovery, assay characterization, standalone patient registries, new trial networks, or intervention studies focused on safety, pharmacokinetics, efficacy, or effectiveness. Eligible applicants include U.S. higher education institutions, nonprofits, for-profits, governments, tribal organizations, faith-based or community-based organizations, and foreign organizations are not eligible; foreign components are not allowed. Awards may request up to $275,000 in direct costs for a 2-year project period, with no more than $200,000 in direct costs in any single year, and cost sharing is not required.

AI-generated summary — verify against the announcement

What it funds

  • Health
  • Income Security and Social Services
  • Research & Discovery
  • Patients & People with Health Conditions
  • Researchers & Scholars
  • Biomedical & Disease Research
Official description from grants.gov

This Notice of Funding Opportunity (NOFO) invites researchers to submit applications for support of clinical projects that address critical needs for clinical trial readiness in rare diseases. The initiative seeks applications that are intended to facilitate rare diseases research by enabling efficient and effective movement of candidate therapeutics or diagnostics toward clinical trials, and to increase their likelihood of success. This could be through the development and testing of rigorous biomarkers and clinical outcome assessment measures, or by defining the presentation and course of a rare disease to enable the design of upcoming clinical trials.

Who can apply

  • City or township governments
  • County governments
  • For-profit organizations other than small businesses
  • Independent school districts
  • Native American tribal governments (Federally recognized)
  • Native American tribal organizations (other than Federally recognized)
  • Nonprofits with 501(c)(3) status (other than higher education)
  • Nonprofits without 501(c)(3) status (other than higher education)
  • Others
  • Private institutions of higher education
  • Public and State controlled institutions of higher education
  • Public housing authorities / Indian housing authorities
  • Small businesses
  • Special district governments
  • State governments
Geographic restriction None found in the announcement — likely nationwide