The Experimental Therapeutics Clinical Trials Network (ETCTN) Lead Academic Organizations (UM1 Clinical Trial Required)

The National Institutes of Health, through the National Cancer Institute, has issued a funding opportunity to support the continuation or establishment of Lead Academic Organizations within the Experimental Therapeutics Clinical Trials Network. This initiative builds on decades of federal investment in early-phase cancer research, particularly through the Cancer Therapy Evaluation Program, which has historically coordinated partnerships among academic institutions, pharmaceutical companies, and investigators to advance novel oncology treatments. The ETCTN framework emphasizes a collaborative, network-based approach to accelerate the evaluation of investigational agents and improve outcomes for patients with cancer, especially in areas of unmet medical need. The primary purpose of this funding opportunity is to enable qualified academic organizations to design, develop, and lead early phase clinical trials, including phase 0, phase 1, phase 2, and pilot studies. These trials focus on investigational drugs and therapeutic combinations under regulatory sponsorship by the National Cancer Institute. Awarded organizations are expected to play a central role in both leading their own trials and participating in trials initiated by other network members, ensuring a coordinated national effort in experimental therapeutics. The program also aims to integrate biomarker analysis, pharmacokinetics, and molecular characterization into clinical research to refine treatment strategies and patient selection. Funding is provided through a cooperative agreement mechanism, reflecting substantial involvement by federal program staff in guiding and coordinating activities. While there is no predefined budget cap for applicants, proposals must justify requested funds based on the scope of proposed activities. The National Cancer Institute anticipates committing approximately 11.8 million dollars to support four to six awards. Each funded project may span up to six years. Allowable costs include personnel, administrative coordination, data management, and clinical trial operations, while certain centralized services such as pharmacokinetic analysis and regulatory infrastructure are provided separately by the agency and must not be included in applicant budgets. Eligibility for this opportunity is broad but specifically tailored to institutions capable of conducting complex clinical research. Eligible applicants include higher education institutions, nonprofit organizations, for-profit entities, and certain governmental or quasi-governmental bodies. However, the program specifically defines eligible organizations as academic centers in the United States or Canada that provide direct patient care and maintain integrated research, training, and clinical infrastructure. These institutions must demonstrate capacity for managing investigational drug trials, including access to investigational pharmacies, advanced imaging, and laboratory capabilities. Only one application per institution is permitted. The application process requires submission through federal grant systems such as Grants.gov or NIH ASSIST, with strict adherence to detailed instructions outlined in the NIH application guide. Applicants must include comprehensive documentation such as organizational structure, clinical trial experience, operational procedures, and evidence of research capabilities. While no specific clinical trials are proposed at the time of application, applicants must demonstrate readiness to design and conduct multiple future trials. Applications are evaluated through a peer review process based on scientific merit, organizational capability, and alignment with program goals. Key dates for the funding opportunity include an opening date of May 30, 2026, and a submission deadline of June 30, 2026. Applications must be submitted by 5:00 PM local time of the applicant organization. Review and award processes follow a structured timeline, with scientific review expected in November 2026, advisory council review in January 2027, and earliest project start dates in April 2027. The funding opportunity expires shortly after the application deadline, and late submissions are not accepted. Applicants are encouraged to engage early with program contacts for guidance and must ensure all required registrations, including SAM and eRA Commons, are completed in advance. The program includes strong expectations for collaboration, mentorship of early-career investigators, and adherence to federal regulatory standards. Through this initiative, the National Cancer Institute seeks to sustain a national infrastructure capable of rapidly advancing promising cancer therapies from early testing stages toward broader clinical application.

Emphasize demonstrated clinical trial infrastructure, prior early-phase trial experience, strong collaboration capacity, and integration of biomarkers and pharmacokinetics into trial design