Opportunity Information: Apply for PAR 18 462
This funding opportunity, titled Clinical Trial Planning: Therapeutic/Indication Pairing Strategies (U34) (Clinical Trials Not Allowed), is a National Institutes of Health (NIH) cooperative agreement (U34) designed to fund the planning work needed before launching an early-stage clinical trial. The focus is not on running a clinical trial under this award, but on doing the up-front planning, feasibility checks, and documentation preparation required to be ready to implement a Phase I and/or Phase II trial that tests a new use for an existing therapeutic.
A central requirement is that the planned clinical trial must be built around drug or biologic repurposing. In other words, applicants must propose a therapeutic and a new disease indication pairing where the drug or biologic has already completed at least a Phase I clinical trial for a different indication by the time the U34 planning award is made. This means the program is aimed at candidates with some existing human safety experience, reducing the uncertainty typically associated with first-in-human development and allowing the planning effort to concentrate on selecting the right new indication, defining an actionable clinical strategy, and preparing a credible early-phase study design.
Another defining feature of this opportunity is how the therapeutic/indication hypothesis is expected to be generated. The pairing must come from innovative identification approaches rather than only traditional, incremental selection. The announcement highlights examples such as independent crowdsourcing strategies and open innovation resources, including public or semi-public listings of experimental drugs or biologics, as well as computational algorithms that can propose new matches between therapeutics and diseases. The intent is to encourage systematic, data-driven, or community-driven methods that can uncover non-obvious repurposing opportunities and then translate those ideas into a well-specified clinical plan.
Because this is a clinical trial planning mechanism, supported activities generally include collecting feasibility data (for example, preliminary clinical operational feasibility, recruitment and site considerations, availability of the patient population, biomarker feasibility, or confirmation that dosing and formulation are appropriate for the new indication), and producing the full set of materials needed to start a Phase I or Phase II study. That planning package typically involves drafting and refining a protocol and statistical analysis plan, building a clinical operations and regulatory strategy, setting up data and safety oversight concepts, developing case report forms and data management approaches, and mapping out timelines, milestone-driven project management, and any required agreements or coordination among partners. As a cooperative agreement, NIH is expected to have substantial involvement during the planning period, meaning awardees should anticipate active collaboration and milestone expectations rather than a hands-off grant.
The opportunity is listed under PAR 18 462 and falls within the Health activity category (CFDA 93.350) under the Department of Health and Human Services, NIH. It was created on Nov 29, 2017, with an original closing date of Nov 16, 2020. The award ceiling is $225,000, and the program anticipated making around 10 awards. Eligibility is broad and includes many types of domestic organizations and governments, such as state, county, city, township, and special district governments; public and private institutions of higher education; Native American tribal governments and tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations (including small businesses and other for-profits); and other applicants as described in the program instructions.
Overall, this U34 is best understood as a bridge between an innovative, evidence-backed repurposing idea and an implementation-ready early-phase clinical trial plan. It supports the disciplined planning work that de-risks and professionalizes a proposed Phase I/II study for a new indication, with the explicit constraint that the award does not pay for conducting the clinical trial itself, only for getting everything prepared so the trial can begin under a subsequent funding mechanism.Apply for PAR 18 462
- The Department of Health and Human Services, National Institutes of Health in the health sector is offering a public funding opportunity titled "Clinical Trial Planning: Therapeutic/Indication Pairing Strategies (U34) (Clinical Trials Not Allowed)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.350.
- This funding opportunity was created on Nov 29, 2017.
- Applicants must submit their applications by Nov 16, 2020. (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 $225,000.00 in funding.
- The number of recipients for this funding is limited to 10 candidate(s).
- 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 (see text field entitled Additional Information on Eligibility for clarification).
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