CLINICAL TRIALS- PROTOCOL SPECIFIC

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The Winship Cancer Institute Clinical Trials Office (WCI CTO) is a Shared Resource of the Cancer Institute that supports clinical research by providing scientific review, prioritization and monitoring of clinical trials involving cancer patients. The long-term goal of the WCI CTO is to advance progress in cancer care through the support of high-quality, high-impact clinical research by Cancer Institute members. The focus of the WCI CTO is to help develop and support institutional clinical research studies, particularly phase 1 and investigator-initiated studies. The CTO supports the clinical research infrastructure that allows WCI investigators to initiate early phase clinical trials, to accrue eligible subjects to clinical research studies, and to complete necessary case report forms and regulatory documents. Dedicated clinical research staff that acquire and process the appropriate clinical samples facilitates clinical studies with correlative laboratory studies, including pharmacokinetic sampling and biomarkers. To achieve the goals of supporting early phase clinical research by WCI investigators that advances the scientific missions of the Programs, the following specific two objectives will be pursued: 1. To initiate and accrue subjects to phase 0, phase 1, and phase 2 institutional clinical research studies that have been authored or co-authored by WCI investigators. 2. To acquire, process, and analyze correlative laboratory samples that advance the scientific goals of the WCI Scientific Programs. Success in the completion of scientifically rigorous institutional phase 1 and 2 clinical trials with novel anticancer agents will lead to consortium and cooperative group phase 3 trials that will validate the efficacy of promising new therapies.