Course Description:
This course introduces the fundamentals of design and analysis of clinical trials. Some of the design issues to be discussed imclude specifying and operationalizing the scientific question of interest, the role of a control group randomization, blinding, and sample size determination. The course will focus on statistical aspects of the analysis of clinical trials, including various statistical estimation and testing procedures, the intent to treat principle, interim analysis, and statistical and scientific inference. Students will learn to critically review published reports of clinical trials through participation in small group discussions and individual written critiques. |