This course will introduce the basic concepts of clinical trials, and the design and statistical analysis of clinical trials at different stage of drug development. Particularly¸ it will focus on practical issues and regulatory considerations. The course includes the following issues: design and requirements of preclinical study to support clinical trial in new drug development, ethical regulations of clinical trials, clinical consideration focus, and study design in Phase I, II, and III clinical trials. In addition, vaccine efficacy and safety evaluation, oncology clinical trials, as well as design of medical device trials, which have been specially concerned in recent years, will also be the focus of this course.
In order to help the students to have a deeper understanding of the course content, this course arranges a practical operation unit using R package. Participants are encouraged to prepare your own laptop and install the R and R STUDIO software in advance.
Participants who attend more than half of the total sessions of the course will be awarded a certificate at the end of the course.