BSTA 6653 - Clinical Trials in the Pharmaceutical and Biomedical Industries

Units: 4
Statistical principles, design, and management of clinical trials. Recruitment, treatment allocation, randomization, blocking, and blinding. Practical applications of advanced statistical procedures for clinical trial data. Ethics of clinical trials design, data collection, data analysis and reporting. Data integrity. Data monitoring. Domestic/International regulatory guidelines emphasized. Use of SAS. Professional protocols are studied. Formal report writing and oral presentation.