Opportunity Information: Apply for RFA TR 19 014

The National Institutes of Health (NIH) funding opportunity RFA-TR-19-014, titled '"Clinical Trials" on a Chip: Tissue Chips to Inform Clinical Trial Design and Implementation in Precision Medicine,' supports projects that put microphysiological systems (MPS), often called tissue chips, to a very practical test: showing how these platforms can directly improve how clinical trials are planned and carried out. The core idea is to generate convincing, late-stage preclinical evidence that tissue chips can inform real clinical trial frameworks by helping researchers anticipate both safety issues and likely efficacy outcomes before human testing. Rather than focusing on basic technology development alone, the emphasis is on applied use cases where tissue chips meaningfully guide decisions that would normally be made with more limited preclinical tools.

A central goal of this program is to strengthen precision medicine by using tissue-chip data to refine trial design. That includes identifying which patient subgroups are most likely to benefit from a candidate therapy, which can translate into clearer recruitment criteria, better stratification strategies, and more efficient trials with stronger signal detection. In practice, applicants are expected to show how their MPS-based approach can help distinguish likely responders from non-responders, support selection of biomarkers or functional readouts that align with patient biology, and reduce uncertainty around dosing or toxicity that might otherwise emerge late in development. The opportunity is framed around demonstrating utility: evidence that the tissue chip system changes or improves the clinical trial plan in a measurable, defensible way.

The mechanism is a cooperative agreement using the UG3/UH3 phased approach, meaning projects typically start with a milestone-driven planning and feasibility stage (UG3) and, if milestones are met, transition into a more advanced implementation stage (UH3). Because it is a cooperative agreement, NIH expects substantial programmatic involvement, such as coordination on milestones, progress assessment, and alignment with the initiative’s broader goals. The announcement is explicitly labeled "Clinical Trial Not Allowed," so funded activities must remain preclinical and cannot include prospective assignment of human participants to interventions. The intent is to inform and de-risk clinical trials, not to run them under this award.

In terms of funding details provided, the award ceiling is listed as $500,000, and the opportunity falls under NIH assistance listings (CFDA) 93.121, 93.350, 93.393, 93.846, and 93.865. The original closing date shown is 2019-10-09, and the opportunity was created on 2019-06-12, indicating this specific solicitation is historical, even though the concept may continue under newer NIH notices or related programs.

Eligibility is broad across public and private sectors. Eligible applicants include state, county, city/township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status; for-profit organizations (other than small businesses); and small businesses. The FOA also highlights additional eligible organization types such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions.

The foreign eligibility rules are specific: non-domestic (non-U.S.) entities and non-domestic components of U.S. organizations are not eligible to apply. However, foreign components, as defined in the NIH Grants Policy Statement, are allowed, which generally means a U.S.-based applicant can include certain foreign collaborations or performance sites if they are well-justified and meet NIH policy requirements.

Overall, this opportunity targets teams that can bridge advanced tissue-chip biology with concrete clinical development decision-making. Competitive projects would be expected to show a credible pathway from chip-generated evidence to actionable trial recommendations, such as how to choose inclusion/exclusion criteria, how to stratify participants, which endpoints or biomarkers to prioritize, and how to anticipate safety liabilities earlier, all while staying firmly on the preclinical side of the translational pipeline.

  • The National Institutes of Health in the education, health, income security and social services sector is offering a public funding opportunity titled ""Clinical Trials" on a Chip: Tissue Chips to Inform Clinical Trial Design and Implementation in Precision Medicine (UG3/UH3 - Clinical Trial Not Allowed)" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.121, 93.350, 93.393, 93.846, 93.865.
  • This funding opportunity was created on 2019-06-12.
  • Applicants must submit their applications by 2019-10-09. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • Each selected applicant is eligible to receive up to $500,000.00 in funding.
  • Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.
Apply for RFA TR 19 014

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