Clinical Trials (531)
This course will illustrate the role of the statistician in a clinical trial. Course topics will include concepts of study design, randomization techniques, and blinding. Statistical issues in equivalency studies, non-inferiority trials, and multi-stage trials will be studied. Specific data analysis techniques such as interim analysis, multiplicity and missing data will be presented. Finally, FDA regulations and writing of statistical analysis plans will be discussed.
Elective course for MS degree
Textbook: Piantadosi, “Clinical Trials: A Methodologic Perspective"