Administrative Supplements for NCI P30 Cancer Center Support Grants The Early Drug Development Opportunity Program (EDDOP)

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The Karmanos Cancer Institute (KCI) is an NCI-designated Comprehensive Cancer and works to foster clinical trial development and conduct. In this capacity, we participate in many trials through the National Clinical Trials Network (NCTN) and are a Lead Academic Participating Site (LAPS). Part of our effort to conduct early clinical trials involved our participation in CATCH-UP.2020. The KCI joined the CATCH-UP NCI program in August 2020. The first trials through this mechanism opened the end of September 2020. We had 19 trials opened under CATCH-UP and 11 are still open to accrual. In the 13 years since the first trial opened, we have enrolled 24 patients. Hence, we should readily be able to enroll at least 5 patients per year with EDDOP support. We now have about 189 interventional trials open to accrual and have in place all the needed procedures to ensure human subjects protection, follow trial methods, and track the studies. We have training mechanisms in place for investigators and staff and ensure that no conflict of interest will affect the trial outcome. Our cores provide for the collection of biospecimens, pharmacokinetic analysis, and quantitative imaging. We routinely do whole exome and transcriptome analysis of tumors from patients with advanced cancer to look for molecular targets are part of our standard of care and for trial identification. Trials are audited and tracked to ensure that accrual is robust and methods are being followed. We have a separate investigational pharmacy to oversee the ordering, storage, dispensing, transport, and tracking of investigational agents. All our procedures are done to meet local, state, and federal regulations and ensure patient safety and the collection of validated trial results.