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.
Possible Instructional Methods: Entirely On-ground, or Entirely Online, or Hybrid.
Grading: A-F grading only.
Course Typically Offered: Fall ONLY

Student Learning Outcomes - Upon successful completion of this course students will be able to:
1. Apply biostatistical methods to data, including (a) descriptive statistics, probability and graphical displays, (b) distributions, hypothesis testing and confidence intervals, and (c) uncertainty, likelihood, modeling and error analysis;
2. Derive basic theory and communicate to others results involving biostatistical data analysis;
3. Formulate problem solutions, produce appropriate computer code and to interpret results.