PTOX 830: Introduction to Clinical and Translational Cancer Research (3)

Instruct students in developmental steps used in translating a basic science experiment with clinical applications into a proof of concept application and human trial. Multidisciplinary approach; lectures from faculty in Pharmacology, KU Cancer Ctr, KUMCRI. Curriculum: Levels of evidence-clinical impact, Pre-Clinical modeling, In-Vitro studies & Animal models, Cancer Drug Development-pharmacokinetics & toxicity, Pre-Clinical Proof of Concept & FDA, Creating a Pilot Study, Biostatistics 101, Phases of Clinical Trials, Data Collection, Support Staff, Regulatory and DSMBs, IRB and HIPPA, Funding Study: Grants & Parma, Advertising study & meeting accrual goals, Goals of Phase I study, Goals & Objectives of Phase II Efficacy study, Phase 3 Multicenter Study: Value of Numbers & Utilizing Cooperative Groups. Prerequisite: Completion of first 2 years of Med School or graduate school, or enrollment in MD/PhD program. Students no meeting one of these criteria will require permission from course instructor. LEC
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