BSTA 663 - Clinical Trials in the Pharmaceutical and Biomedical Industries

Units: 2
Statistical principles, design, management of clinical trials. Topics include: recruitment, treatment allocation, stratification, blinding. Practical applications. Ethics of clinical trials. Data collection, data analysis. Data integrity, monitoring. Domestic/international regulatory guidelines emphasized. Professional protocols. Introduction to CDISC. Report writing, oral presentation.

Prerequisites: BSTA 662.
Equivalent Quarter Course: BSTA 6653.
Possible Instructional Methods: Entirely On-ground.
Grading: A-F grading only.