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.
Student Learning Outcomes - Upon successful completion of this course students will be able to:

Apply appropriate methods to describe and present clinical trial data in summaries, tables and/or graphs.
Formulate solutions to problems and develop statistical models involving clinical trial data.
Program appropriate SAS procedures to produce appropriate graphs, reports, and statistical output.
Communicate results to others regarding clinical trial design and analysis.