The Winship Cancer Institute (Winship) accords highest priority to the conduct of high-impact clinical research developed by its member investigators as an extremely high priority. CCSG Protocol-Specific Research support will provide available resources of the Winship Clinical Trials Office (CTO) and the Phase I Clinical Trials Unit (CTU) to support institutional clinical research studies, for investigator-initiated phase I and II studies. Winship investigators have successfully completed and reported on phase I studies utilizing clinical research infrastructure support from the CTO that includes the acquisition of critical clinical samples in the specialized Phase I CTU. Dedicated clinical research staff members who acquire and process clinical samples for pharmacokinetic, pharmacodynamic, and biomarker sampling can be made available with this support. To achieve the goals of supporting early phase, investigator-initiated clinical research by Winship investigators, the following specific two objectives will be pursued: 1. To identify, initiate, and complete accrual to phase 0, phase I, and phase II institutional clinical research studies which have been authored or co-authored by Winship investigators. 2. To acquire, process, and analyze correlative laboratory samples which advance the scientific goals of the Winship research programs. Success in the completion of scientifically rigorous institutional clinical trials with novel anti-cancer agents will lead to consortium and cooperative group trials that will validate the efficacy of promising new therapies.
; The protocol specific research support facilitates the conduct of high-quality early phased clinical trials at Winship. This avenue also encourages inclusion of translational research as an integral component of such clinical trials.
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