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“FDA and the Drug Approval Process” is an introductory review of clinical research. It outlines the fundamental tactics for conducting evidence-based clinical trials that we use here in the US to evaluate the safety and efficacy of drug and medical devices to be used in humans. After describing the history and logic behind various clinical trial designs, and the protection of human subjects who participate in such trials, this talk will review more recently developed strategies that will allow more patients with increasingly complex medical conditions to be incorporated into the research process. Finally, it will identify some difficult issues and questions that clinical research professionals will be confronting in the years ahead. Dr. James Parmentier received his AB degree in Biology from Princeton, and PhD in Biological Sciences from UC Santa Barbara, studying chemoreception and the mechanisms of action of neurotransmitters. He has extensive experience in academic medicine as well as a researcher for the pharmaceutical industry. He has served as Chief investigator at the Mass General Hospital Institute of Health Professions, and also as a member of the Rutgers School of Health Professions. He retired as an Associate Professor from the Rutgers faculty in 2014.

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