Pharmaceutical Statistics

Course Description: This course reviews major components of the drug development process and the conduct of clinical trials. Specific topics include (1) introduction to clinical trials, (2) formulation of clinical hypotheses and study endpoints, (3) preclinical studies, (4) design, analysis, and reporting of phase I, II, and III clinical trials, (5) phase IV studies and post-marketing surveillance, (6) Statistical considerations for clinical trials, (7) regulatory aspects for drug development, (8) Longitudinal data with dropouts, (9) Subgroup analysis, and (10) Non-inferiority trials.

Textbook: Evans and Ting. (2015). Fundamental Concepts for New Clinical Trialists. Chapman & Hall/CRC.

Sample slides below