Opportunity Information: Apply for RFA CA 27 016
The Experimental Therapeutics Clinical Trials Network (ETCTN) Lead Academic Organizations (UM1 Clinical Trial Required) opportunity (RFA-CA-27-016) is a National Cancer Institute (NCI) funding announcement that supports a small set of academic institutions to serve as Lead Academic Organizations (LAOs) within NCI's ETCTN. The central purpose is to ensure the network has strong, well-resourced academic hubs that can take responsibility for the full lifecycle of NCI-sponsored early phase oncology trials, from initial concept and protocol development through operational execution, data analysis, and reporting. Because this is a UM1 cooperative agreement, awardees are expected to work closely with NCI program staff, and the relationship is more collaborative and structured than a typical research project grant.
Functionally, an ETCTN LAO is expected to design, develop, monitor, conduct, and analyze experimental therapeutics clinical trials, especially early phase studies such as phase 0, phase 1, phase 2, and pilot trials. These studies will involve investigational cancer agents that fall under NCI's regulatory sponsorship, specifically New Investigational Drug (IND) applications held by NCI's Division of Cancer Treatment and Diagnosis (DCTD), Cancer Therapy Evaluation Program (CTEP). In other words, the trials are built around NCI-supported investigational agents, and the LAO plays a leading role in translating those agents into carefully designed human studies that evaluate safety, dosing, early signals of activity, pharmacodynamics, and other endpoints that are typical for early development.
A defining feature of the ETCTN model, reflected in this NOFO, is that each LAO is not only responsible for trials it leads but is also expected to participate in trials led by other LAOs across the network. That network-wide expectation matters because it implies operational readiness to open and accrue to protocols developed elsewhere, harmonize procedures across sites, and collaborate on shared trial infrastructure. The goal is a coordinated national (and limited international) platform that can move promising therapeutic ideas through early clinical testing efficiently, using consistent standards for trial conduct, oversight, and analysis.
Eligibility is framed in a way that prioritizes academically oriented clinical research environments with robust translational capabilities. For the purposes of this NOFO, an eligible institution is described as an academic center or organization in the United States or Canada that provides direct medical care to patients and operates as a single integrated organizational entity under one financial management system and governance structure. The announcement draws a line between these academic entities and large medical centers whose primary mission is patient care, emphasizing that LAOs should have the broader academic and research ecosystem needed for experimental therapeutics work. In practical terms, the NOFO highlights characteristics typically required to run complex early phase oncology studies, including comprehensive medical training programs, investigational pharmacy capabilities, advanced imaging resources, and preclinical laboratories that conduct basic research. These elements collectively support the specialized workflows of first-in-human and other early trials, such as handling investigational agents, performing intensive safety monitoring, conducting correlative science, and integrating imaging and laboratory endpoints.
The foreign eligibility rules are narrow and specific. Canadian institutions are the only non-U.S. entities explicitly permitted to apply in response to this NOFO. At the same time, the notice states that non-U.S. components of U.S. organizations are not eligible to apply, and foreign components (as defined in NIH policy) are not allowed. The net effect is that the network is intended to be anchored in the U.S. with a defined allowance for Canadian academic centers, while generally restricting other foreign involvement at the applicant or component level.
From an administrative standpoint, the opportunity is issued by the National Institutes of Health (NIH) under NCI, uses the cooperative agreement funding instrument (UM1), and falls under a health-related activity category (CFDA 93.395). The posting indicates an expected number of awards of six, with an original application due date of June 30, 2026. The eligible applicant types listed are broad across government, higher education, nonprofit, and for-profit categories; however, the NOFO's specific LAO definition effectively narrows practical eligibility to integrated academic clinical organizations with the required patient care and research infrastructure, and with the ability to operate as a single governed entity suitable for leading and participating in multi-site early phase trials within the ETCTN.Apply for RFA CA 27 016
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "The Experimental Therapeutics Clinical Trials Network (ETCTN) Lead Academic Organizations (UM1 Clinical Trial Required)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.395.
- This funding opportunity was created on 2026-05-08.
- Applicants must submit their applications by 2026-06-30. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The number of recipients for this funding is limited to 6 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.
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Frequently Asked Questions (FAQs): ETCTN Lead Academic Organizations (UM1 Clinical Trial Required) - RFA-CA-27-016
1) What is this funding opportunity?
This opportunity, titled Experimental Therapeutics Clinical Trials Network (ETCTN) Lead Academic Organizations (UM1 Clinical Trial Required) (RFA-CA-27-016), is a National Cancer Institute (NCI) funding announcement issued through the National Institutes of Health (NIH). It supports a small set of institutions to serve as Lead Academic Organizations (LAOs) within NCI's ETCTN.
2) What is the main purpose of funding ETCTN Lead Academic Organizations (LAOs)?
The central purpose is to ensure the ETCTN has strong, well-resourced academic hubs that can take responsibility for the full lifecycle of NCI-sponsored early phase oncology trials, including:
- Initial concept development
- Protocol development
- Operational execution
- Data analysis
- Reporting
3) What does it mean that this is a UM1 cooperative agreement?
The award uses the UM1 cooperative agreement mechanism. Awardees are expected to work closely with NCI program staff, and the relationship is described as more collaborative and structured than a typical research project grant.
4) What kinds of clinical trials are LAOs expected to lead and support?
ETCTN LAOs are expected to design, develop, monitor, conduct, and analyze experimental therapeutics clinical trials, with emphasis on early phase oncology studies such as:
- Phase 0 trials
- Phase 1 trials
- Phase 2 trials
- Pilot trials
5) What types of investigational agents will these trials involve?
The trials will involve investigational cancer agents under NCI's regulatory sponsorship, specifically New Investigational Drug (IND) applications held by NCI through the Division of Cancer Treatment and Diagnosis (DCTD), Cancer Therapy Evaluation Program (CTEP).
6) What does "NCI-sponsored early phase oncology trials" imply for LAO responsibilities?
Based on the description, LAOs are expected to take a leading role in translating NCI-supported investigational agents into human studies that evaluate endpoints typical of early development, such as:
- Safety
- Dosing
- Early signals of activity
- Pharmacodynamics
- Other early-phase endpoints
7) Are LAOs only responsible for trials they lead?
No. A defining feature of the ETCTN model in this announcement is that each LAO is expected to both:
- Lead trials it develops, and
- Participate in trials led by other LAOs across the network
8) What does network-wide participation require operationally?
The announcement indicates that LAOs should be operationally ready to:
- Open and accrue to protocols developed by other LAOs
- Harmonize procedures across participating sites
- Collaborate on shared trial infrastructure
9) What is the overall vision of the ETCTN platform described in this opportunity?
The goal is a coordinated national (and limited international) platform to move promising therapeutic ideas through early clinical testing efficiently, using consistent standards for trial conduct, oversight, and analysis.
10) Who is considered eligible to apply as an institution?
For purposes of this NOFO, an eligible institution is described as an academic center or organization in the United States or Canada that:
- Provides direct medical care to patients
- Operates as a single integrated organizational entity
- Has one financial management system and governance structure
11) What kinds of organizations does the NOFO prioritize in practice?
While applicant type categories are listed broadly, the LAO definition effectively narrows practical eligibility to academically oriented clinical research environments with robust translational capabilities and the infrastructure needed for complex early phase oncology trials.
12) How does the NOFO distinguish LAOs from large medical centers focused mainly on patient care?
The announcement emphasizes that LAOs should have a broader academic and research ecosystem needed for experimental therapeutics work, as distinct from large medical centers whose primary mission is patient care.
13) What infrastructure and capabilities are highlighted as important for an LAO?
The NOFO highlights characteristics typically required to run complex early phase oncology studies, including:
- Comprehensive medical training programs
- Investigational pharmacy capabilities
- Advanced imaging resources
- Preclinical laboratories that conduct basic research
14) Why are these capabilities important for early phase experimental therapeutics trials?
The announcement links these capabilities to specialized early phase workflows, such as handling investigational agents, performing intensive safety monitoring, conducting correlative science, and integrating imaging and laboratory endpoints.
15) Are non-U.S. institutions eligible to apply?
Foreign eligibility is narrow: Canadian institutions are the only non-U.S. entities explicitly permitted to apply in response to this NOFO.
16) Are foreign components of U.S. organizations allowed under this NOFO?
No. The notice states that non-U.S. components of U.S. organizations are not eligible to apply, and that foreign components (as defined in NIH policy) are not allowed.
17) What does the foreign eligibility approach imply about the network's structure?
The described rules indicate the network is intended to be anchored in the United States, with a defined allowance for Canadian academic centers, while generally restricting other foreign involvement at the applicant or component level.
18) Which NIH institute is issuing this opportunity, and under what activity area?
This opportunity is issued by NIH under the National Cancer Institute (NCI) and falls under a health-related activity category with CFDA 93.395.
19) How many awards are expected?
The posting indicates an expected number of awards of six.
20) What is the application due date listed?
The original application due date shown is June 30, 2026.
21) What kinds of applicant organization types are listed as eligible?
The eligible applicant types listed are broad, spanning:
- Government
- Higher education
- Nonprofit organizations
- For-profit organizations
However, the NOFO's specific LAO definition effectively narrows practical eligibility to integrated academic clinical organizations that provide direct patient care and can function as a single governed entity capable of leading and participating in multi-site early phase trials.
22) What are the core expectations for an LAO within ETCTN, based on this description?
Based on the information provided, core expectations include:
- Serving as a well-resourced academic hub for early phase oncology trials
- Leading the end-to-end process for trials, from concept through reporting
- Conducting trials involving NCI-held IND agents (DCTD/CTEP)
- Participating in other LAO-led ETCTN trials across the network
- Maintaining infrastructure for investigational agents, safety monitoring, imaging, and laboratory-correlative endpoints
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