This advanced-level course reviews the science that forms the basis for effective clinical trial design. Topics include classifying and describing trial design by stage in drug/device development; types of trial designs; defining the hypothesis and study objectives; safety information and DSMBs; determining the population and sample size; study procedures; identifying and selecting clinically meaningful endpoints; scientific/ethical considerations; and statistical validity of design, execution, analysis, and reporting.
Other Credits: BRN: 24 CE hours.
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, Medical Writing
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6/25/2018 - 9/8/2018