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.Apply for RFA TR 19 014
- 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.
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Frequently Asked Questions (FAQs)
What is the NIH funding opportunity RFA-TR-19-014 about?
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 use microphysiological systems (MPS), often called tissue chips, to generate late-stage preclinical evidence that can directly improve how clinical trials are designed and carried out in precision medicine. The focus is on practical, decision-shaping use cases rather than basic tissue-chip technology development alone.
What is the main goal of the program?
The main goal is to demonstrate, with convincing late-stage preclinical data, that tissue chips can meaningfully inform real clinical trial frameworks. This includes helping teams anticipate safety issues and likely efficacy outcomes before human testing, and showing that the tissue-chip evidence leads to measurable, defensible improvements in clinical trial planning.
What kinds of outcomes is NIH looking for from tissue-chip data?
NIH is looking for evidence that tissue-chip results translate into actionable trial recommendations, such as better inclusion/exclusion criteria, improved participant stratification, more efficient recruitment strategies, selection of biomarkers or functional readouts aligned with patient biology, and reduced uncertainty around dosing or toxicity that might otherwise emerge later in development.
How does this opportunity support precision medicine specifically?
The opportunity emphasizes using tissue-chip data to refine trial design for precision medicine by identifying which patient subgroups are most likely to benefit from a candidate therapy. This can support clearer recruitment criteria, stronger stratification approaches, and more efficient trials with improved signal detection.
Is this opportunity intended for basic tissue-chip technology development?
No. While tissue chips are central to the work, the emphasis is on applied use cases demonstrating utility in informing clinical trial design and implementation decisions. The program is framed around showing that the tissue-chip system changes or improves the clinical trial plan in a measurable and defensible way, rather than focusing on basic platform development alone.
What does the FOA mean by '"Clinical Trials" on a Chip'?
It refers to using tissue chips as a preclinical system to simulate and evaluate key aspects of clinical testing. The intent is to generate evidence that can guide clinical trial decisions (for example, safety risks, likely efficacy, patient subgroup selection) before moving into human trials.
Does this funding opportunity allow conducting clinical trials with human participants?
No. The announcement is explicitly labeled "Clinical Trial Not Allowed." Funded activities must remain preclinical and cannot include prospective assignment of human participants to interventions. The award is meant to inform and de-risk clinical trials, not to run clinical trials under this funding.
What is the funding mechanism for this opportunity?
The mechanism is a cooperative agreement using the UG3/UH3 phased approach. Projects typically begin with a milestone-driven planning and feasibility stage (UG3) and, if milestones are met, transition to a more advanced implementation stage (UH3).
What does the UG3/UH3 phased approach imply for project structure?
It implies a two-phase structure: an initial UG3 phase focused on planning, feasibility, and meeting defined milestones, followed by a UH3 phase that supports more advanced implementation if the UG3 milestones are achieved. Progression is milestone-dependent.
What does it mean that this is a cooperative agreement?
As a cooperative agreement, NIH expects substantial programmatic involvement. This includes coordination on milestones, progress assessment, and alignment with the broader goals of the initiative, rather than NIH acting only as a passive funder.
What is the award ceiling listed for this opportunity?
The award ceiling listed in the provided information is $500,000.
Which NIH assistance listings (CFDA) are associated with this FOA?
The opportunity is associated with NIH assistance listings (CFDA) 93.121, 93.350, 93.393, 93.846, and 93.865.
When was this opportunity created and when did it close?
The opportunity was created on 2019-06-12, and the original closing date shown is 2019-10-09. Based on these dates, the specific solicitation described is historical, even if similar concepts may appear in newer NIH notices or related programs.
Who is eligible to apply?
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.
Are specific institution types highlighted as eligible?
Yes. The FOA 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.
Can non-U.S. organizations apply directly?
No. Non-domestic (non-U.S.) entities are not eligible to apply directly based on the foreign eligibility rules provided.
Are non-domestic components of U.S. organizations eligible to apply?
No. Non-domestic components of U.S. organizations are not eligible to apply, according to the provided rules.
Are foreign components allowed in a project led by a U.S. applicant?
Yes. Foreign components, as defined in the NIH Grants Policy Statement, are allowed. This generally means a U.S.-based applicant may include certain foreign collaborations or performance sites if well-justified and consistent with NIH policy requirements.
What kind of evidence is the program trying to generate?
The program aims to generate convincing, late-stage preclinical evidence that tissue-chip platforms can inform real clinical trial frameworks. This includes evidence relevant to both safety (such as anticipating toxicity) and likely efficacy outcomes, with the explicit goal of improving clinical trial planning decisions.
What are examples of clinical trial design decisions that tissue chips could influence under this FOA?
Based on the description, tissue-chip data could influence decisions such as identifying likely responders versus non-responders, recommending patient subgroup selection approaches, informing inclusion/exclusion criteria, supporting stratification strategies, prioritizing endpoints and biomarkers or functional readouts, and reducing uncertainty around dosing or toxicity before human testing.
What is meant by demonstrating "utility" in this FOA?
Demonstrating utility means showing that the tissue-chip system produces evidence that changes or improves the clinical trial plan in a measurable and defensible way, compared with relying only on more limited preclinical tools.
What is the program trying to avoid funding?
Based on the information provided, the program is not intended to fund clinical trials involving prospective assignment of human participants to interventions, and it is not focused on basic technology development alone without a clear, applied pathway to informing clinical trial design and implementation.
What kinds of teams are a good fit for this opportunity?
The opportunity targets teams that can bridge advanced tissue-chip biology with concrete clinical development decision-making. Competitive projects would be positioned to connect chip-generated evidence to actionable trial recommendations while remaining firmly on the preclinical side of the translational pipeline.
What does it mean to "de-risk" clinical trials in this context?
In this context, de-risking means using preclinical tissue-chip evidence to anticipate safety liabilities and likely efficacy outcomes earlier, reduce uncertainty around dosing or toxicity, and improve trial planning decisions before human testing begins.
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