OpportunityTitle: Forecast to Publish a Notice of Funding Opportunity for The Experimental Therapeutics Clinical Trials Network (ETCTN) Lead Academic Organizations (UM1 Clinical Trial Required)
Description: The National Cancer Institute (NCI) intends to publish a Notice of Funding Opportunity (NOFO) to solicit applications from institutions/organizations that propose to maintain or establish Lead Academic Organizations (LAOs) as part of the NCI Experimental Therapeutics Clinical Trials Network (ETCTN). ETCTN LAOs will design, develop, monitor, conduct, and analyze early phase clinical trials (e.g., phase 0, phase 1, phase 2, pilot, and other experimental therapeutic clinical trials) involving agents under regulatory sponsorship for New Investigational Drug (IND) applications held by NCI&apos;s Division of Cancer Treatment and Diagnosis (DCTD), Cancer Therapy Evaluation Program (CTEP). Each ETCTN LAO will participate in clinical trials it leads as well as clinical trials led by other LAOs in the network.  The ETCTN LAOs will provide oversight for all scientific, programmatic, financial, and administrative matters related to the sites participating in ETCTN trials as part of their LAOs. ETCTN LAOs are also expected to provide mentorship for investigators who are in the early stages of their research careers with a focus on clinical trials. All ETCTN LAOs will be required to use the ETCTN Pharmacokinetic (PK) Resource Laboratory as a central resource to incorporate PK studies within their early phase clinical trials, when appropriate, to analyze pharmacokinetic endpoints, drug-drug interactions, cytochromes P450 (CYP) interactions, pharmacodynamics, and food effects associated with IND agents being evaluated in ETCTN trials. This PK Laboratory will conduct all pharmacokinetic studies for ETCTN clinical trials involving Investigational New Drug (IND) agents under the regulatory sponsorship of NCI&#8217;s Division of Cancer Treatment and Diagnosis (DCTD), Cancer Therapy Evaluation Program (CTEP). The ETCTN Pharmacokinetic Resource Laboratory is funded through a separate NOFO (RFA-CA-25-027).  Applications are not being solicited at this time. Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. This NOFO will utilize the UM1 activity code. The NOFO is expected to be published in Summer 2025 with an anticipated application due date in Fall 2025.
GrantorContactEmailDescription: NCIETCTNRFA@mail.nih.gov