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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Frequently Asked Questions (FAQs)
1) What is the title of this funding opportunity?
The opportunity is titled Clinical Trial Planning: Therapeutic/Indication Pairing Strategies (U34) (Clinical Trials Not Allowed).
2) Which agency is offering this grant?
This is a National Institutes of Health (NIH) funding opportunity within the U.S. Department of Health and Human Services (HHS).
3) What type of award is this?
It is a cooperative agreement (U34). Under a cooperative agreement, NIH is expected to have substantial involvement during the project period, which typically means active collaboration, milestone expectations, and an interactive planning process rather than a hands-off grant.
4) What is the overall purpose of this U34?
This U34 supports the planning work needed before launching an early-stage clinical trial. The intent is to move a strong repurposing concept to an implementation-ready Phase I and/or Phase II clinical trial plan by completing feasibility checks and producing the documentation and operational/regulatory materials needed to start the trial under a later mechanism.
5) Are clinical trials allowed under this award?
No. The opportunity explicitly states Clinical Trials Not Allowed. The award funds planning and preparation activities, not the actual conduct of a clinical trial.
6) What stage of clinical research is the planning intended to support?
The planning work is aimed at preparing for an early-stage clinical trial, specifically a Phase I and/or Phase II study (to be conducted later, outside this U34).
7) What kind of therapeutic approach is required?
The planned trial must be built around drug or biologic repurposing. Applicants must propose a therapeutic and new disease indication pairing that tests a new use for an existing therapeutic.
8) What is required regarding prior human testing of the therapeutic?
By the time the U34 planning award is made, the drug or biologic must have already completed at least a Phase I clinical trial for a different indication. This requirement implies there is existing human safety experience for the product before planning a new-indication early-phase trial.
9) Does the new indication have to be different from the therapeutic's prior indication?
Yes. The concept is to evaluate the therapeutic in a new disease indication, distinct from the indication in which it previously completed Phase I testing.
10) How is the therapeutic/indication pairing expected to be identified?
The pairing is expected to come from innovative identification approaches rather than only traditional, incremental selection. The announcement highlights methods such as:
- Independent crowdsourcing strategies
- Open innovation resources, including public or semi-public listings of experimental drugs or biologics
- Computational algorithms that propose new matches between therapeutics and diseases
The intent is to encourage systematic, data-driven, or community-driven approaches that can surface non-obvious repurposing opportunities and translate them into a credible clinical plan.
11) What kinds of activities can the U34 budget support?
Supported activities are generally those needed to plan, validate feasibility, and prepare to initiate a Phase I/II trial. Examples described include:
- Collecting feasibility data (for example: preliminary clinical operational feasibility, recruitment and site considerations, availability of the patient population)
- Biomarker feasibility work (as applicable)
- Confirming dosing and formulation suitability for the new indication
- Drafting and refining a clinical protocol
- Developing a statistical analysis plan
- Building clinical operations and regulatory strategy
- Setting up data and safety oversight concepts
- Developing case report forms and data management approaches
- Creating timelines, milestone-driven project management plans, and coordination plans among partners
- Preparing any required agreements or coordination structures among collaborators
12) What does "planning package" mean in the context of this U34?
In this opportunity, the "planning package" refers to the full set of materials needed to start a Phase I or Phase II study, including the protocol, analysis plan, operational and regulatory strategy, data/safety oversight concepts, data collection tools, and milestone-based implementation planning.
13) What should applicants expect from NIH involvement during the planning period?
Because this is a cooperative agreement, NIH is expected to be actively involved. Awardees should anticipate ongoing collaboration and milestone expectations during the planning period.
14) What is the funding ceiling for this opportunity?
The award ceiling listed is $225,000.
15) How many awards were anticipated?
The opportunity anticipated making approximately 10 awards.
16) What is the program identifier for this opportunity?
The opportunity is listed under PAR 18 462.
17) What is the activity category and CFDA number?
It falls under the Health activity category and lists CFDA 93.350.
18) When was this opportunity created, and what was the original closing date?
It was created on Nov 29, 2017, and the original closing date is listed as Nov 16, 2020.
19) Who is eligible to apply?
Eligibility is broad and includes many types of domestic organizations and governments, including:
- 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)
- Other applicants as described in the program instructions
20) Is this opportunity focused on discovering brand-new drugs?
No. The focus is on repurposing an existing drug or biologic that has already completed at least a Phase I clinical trial (for another indication). The planning effort is aimed at selecting and justifying a new indication and preparing an early-phase clinical plan.
21) What is the central "fit" test for whether a project belongs in this program?
A strong fit is a project that (1) proposes a repurposed drug/biologic with prior Phase I experience, (2) uses an innovative method (crowdsourcing/open innovation/computational matching) to generate the therapeutic/indication pairing, and (3) needs funding specifically to perform feasibility and trial-startup planning to reach a Phase I/II trial-ready state (without conducting the trial under this award).
22) What is the main outcome this U34 is trying to achieve?
The main outcome is a disciplined, credible, implementation-ready plan for a Phase I and/or Phase II clinical trial evaluating a new indication for an existing therapeutic, including the feasibility evidence and documentation needed to begin the trial using a subsequent funding mechanism.
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