This course will introduce the design and statistical analysis of clinical trials at different stage of drug development. Practical issues and regulatory considerations will be particularly focused. The course includes the following issues: design and analysis of clinical trial in phase I, II, and III, randomization methods, sample size estimation, group sequential design and adaptive design, multiplicity and testing strategy, safety and efficacy evaluation in vaccine trial, and design and evaluation for medical device including in vitro diagnostic devices (IVD).
In addition, the course will arrange two practical operations using R package to help the students for a deeper understanding. Participants are encouraged to prepare your own laptop and install the R and R STUDIO software in advance. For those who complete the 10 main lectures (not necessary the practical operations) will be awarded a certificate at the end of the course.
(Completion of the expected ten training courses will be awarded a certificate of completion)
(Organized by: Academia Sinica Data Science Statistical Cooperation Center)