Forecast to Publish a Notice of Funding Opportunity for the Experimental Therapeutics Clinical Trials Network (ETCTN) Pharmacokinetic Resource Laboratory (U24 Clinical Trial Not Allowed)

The National Cancer Institute (NCI) intends to publish a Notice of Funding Opportunity (NOFO) solicits applications from institutions/organizations that propose to maintain or establish a Pharmacokinetics Resource Laboratory (PK Laboratory) to support the Experimental Therapeutics Clinical Trials Network (ETCTN). The PK Laboratory will organize biospecimen collections and provide subsequent analyzes of pharmacokinetic endpoints, drug-drug interactions, cytochrome P450 (CYP) interactions, pharmacodynamics, and food effects in ETCTN studies of NCI Investigational New Drug (IND) agents. The overarching goal of the ETCTN PK Laboratory is to advance the clinical development of NCI IND agents by providing a comprehensive understanding of pharmacokinetic behavior of these agents under study in ETCTN trials. The ETCTN PK Laboratory will engage physicians, clinical pharmacologists, nurses, and scientists who have appropriate expertise in pharmacokinetic studies for early drug development and translational research. This NOFO seeks U24 applications from multidisciplinary institutions/organizations to conduct all pharmacokinetic studies for ETCTN early phase clinical trials filed to IND applications in the NCI Division of Cancer Treatment and Diagnosis (DCTD), Cancer Therapy Evaluation Program (CTEP).

Applicants for this NOFO are expected to have in place a standing infrastructure to support PK studies for ETCTN clinical trials from trial initiation through clinical development of NCI-IND agents. The ETCTN Pharmacokinetics Resource Laboratory application must include the following 3 functional components:

Technical Services Core - This functional component should provide the technical services for the full range of PK and associated assays and analyzes needed to support ETCTN clinical trials.

Scientific Leadership and Project Development Core - This functional component should provide scientific leadership and expertise for a team-science approach to project development in support of PK activities for the ETCTN.

Biospecimen Collection, Tracking, Processing and Data Reporting Core - This functional Component should provide an integrated system/service for the collection, tracking, and processing of biospecimens from the ETCTN Lead Academic Organizations and their participating sites for ETCTN clinical trials.

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 U24 activity code. The NOFO is expected to be published in Summer 2025 with an anticipated application due date in Fall 2025.