This course will provide an overview of how to design, conduct and analyze clinical trials. Completion of this course will lead to an understanding of the theoretical and practical aspects of clinical trials related to the strengths and limitations of randomized clinical trials; theoretical and practical aspects of randomization, stratification, and blinding; challenges of designing and implementing single-center and multi-center clinical trials; major issues in the analysis of clinical trials; role of clinical trials in the drug development process; and investigators’ roles and responsibilities in conducting clinical trials.