This course reviews the nuts-and-bolts of effective clinical trial design and the basic anatomy of a clinical trial. Topics include trial designs by stage in drug/device development; the various types of trial designs and when they apply; defining the hypothesis and study objectives; defining clinically meaningful safety and efficacy endpoints and study procedures; selecting the study population and determining sample size; scientific/ethical considerations; and data analyses and statistical considerations.
Note: Prerequisite: The Drug Development Process, FPM 40173. Elective for Professional Certificate in Clinical Trials Design and Management.
Course Number: FPM-40205
Credit: 3.00 unit(s)
Related Certificate Programs: Clinical Trials Design and Management
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7/6/2020 - 9/5/2020