Clinical Trial Design and Analysis

3 credits · Allied Health Graduate Program

Topics include history/background and process for clinical trial, key concepts for good statistics practice (GSP)/good clinical practice (GCP), regulatory requirement for pharmaceutical/clinical development, basic considerations for clinical trials, designs for clinical trials, classification of clinical trials, power analysis for sample size calculation, statistical analysis for efficacy evaluation, statistical analysis for safety assessment, implementation of a clinical protocol, statistical analysis plan, data safety monitoring, adaptive design methods in clinical trials (general concepts, group sequential design, dose-finding design, and phase I/II or phase II/III seamless design) and controversial issues in clinical trials. Prerequisite(s): BIOSTAT 706/706A or permission of the director of graduate studies. Credits: 3