This course will provide students with a more in-depth understanding of clinical trial design, conduct and strategy for therapeutic products. Clinical trial design elements will be examined in the context of their impact on clinical trial outcomes. Emphasis will be placed upon trial designs that reflect the biological nature and mechanism of action of the therapeutic product being tested, rather than a cookbook approach. Design elements related to small molecules, antibodies, therapeutic proteins, therapeutic vaccines, and cell and gene therapies will be discussed. Discussions will include operational issues impacting execution of clinical trials and why they are critical elements of successful clinical development programs. Students will gain an understanding of the principles for use of particular biostatical testing procedures and in what context certain methods should be used. There will be an emphasis on clinical development problem solving as students work on team projects and defend their own clinical development solutions in the context of product profiles, strategy and timelines. (ALS 433)
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