The Experimental Therapeutics Clinical Trials Network (UM1 Clinical Trials Required) | RFA CA 19 007

Opportunity Information: Apply for RFA CA 19 007

The National Cancer Institute (NCI), part of the National Institutes of Health (NIH), issued this Funding Opportunity Announcement (FOA) to continue and strengthen the Experimental Therapeutics Clinical Trials Network (ETCTN). The ETCTN exists to make early phase cancer drug development more efficient by ensuring there is a ready, coordinated set of investigators, clinical programs, and supporting infrastructure capable of running high-quality experimental therapeutics studies. In practical terms, the opportunity is focused on moving promising cancer agents into human testing in a way that is organized, scientifically rigorous, and fast enough to inform subsequent development decisions.

This FOA invites applications for a UM1 cooperative agreement, which means awardees are expected to work in close partnership with NCI rather than operating with complete independence. The network’s central mission under this solicitation is to conduct early phase clinical trials, including phase 0, phase 1, phase 2, pilot studies, and other experimental therapeutics trials. The agents of interest are those for which NCI’s Division of Cancer Treatment and Diagnosis (DCTD), through the Cancer Therapy Evaluation Program (CTEP), holds Investigational New Drug (IND) status. That point matters because it signals these are NCI-sponsored investigational agents, and the ETCTN sites and teams are expected to be able to implement the specific operational, regulatory, data, and scientific requirements that come with trials of NCI IND drugs.

The applications sought are from multidisciplinary groups that can assemble and maintain the infrastructure needed to run these trials. While the announcement does not list every required component in the excerpt, the intent is clearly to support organizations that can reliably execute complex early phase oncology studies and associated translational research activities. This typically implies capabilities such as experienced early drug development investigators, robust clinical trial operations, timely participant accrual, strong safety monitoring and dose-escalation expertise, and the ability to support correlative and translational endpoints that help explain drug mechanism, response, and resistance. The ETCTN design also emphasizes having teams and programs with deep expertise in translational research so that early clinical findings can be meaningfully linked back to biology and used to guide next steps.

Eligibility is broad and explicitly inclusive. The FOA is open to any qualified applicant, including groups not previously affiliated with the ETCTN. Eligible applicant types listed in the source data include state governments; public or state-controlled institutions of higher education; private institutions of higher education; nonprofit organizations (both 501(c)(3) and non-501(c)(3), other than institutions of higher education); for-profit organizations other than small businesses; and small businesses. The announcement also calls out additional categories of eligible applicants, including 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), and U.S. territories or possessions. Foreign participation is permitted in specific ways: non-domestic (non-U.S.) entities (foreign organizations and foreign institutions) are eligible to apply, foreign components as defined by NIH policy are allowed, but non-domestic components of U.S. organizations are not eligible to apply. Because these distinctions can be nuanced, applicants are directed to the full funding announcement for the detailed rules.

From an administrative standpoint, the opportunity is identified as RFA-CA-19-007, categorized as discretionary funding, and uses the cooperative agreement mechanism. The activity area is listed under education and health, and the associated CFDA number is 93.395. The original closing date shown is May 22, 2019, with an award ceiling listed at $1,250,000. The source excerpt does not specify the number of expected awards, but the overall structure indicates NCI intended to fund multiple network components capable of carrying out the ETCTN mission.

Overall, this FOA is best understood as NCI’s effort to maintain a high-performing, collaborative clinical trials network specifically optimized for early phase testing of NCI-held IND cancer agents. Awardees are expected to bring the people, systems, and clinical research environment needed to open and run these trials efficiently, generate high-quality safety and preliminary efficacy data, and integrate translational science so that results can rapidly inform future development and therapeutic strategy.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "The Experimental Therapeutics Clinical Trials Network (UM1 Clinical Trials 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 2019-01-10.
• Applicants must submit their applications by 2019-05-22. (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 $1,250,000.00 in funding.
• Eligible applicants include: State governments, Public and State controlled institutions of higher education, 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 CA 19 007

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