Clinical trials are a type of research that studies new tests and treatment and evaluates their effects on human health outcomes. Randomized controlled trials are considered as the gold standard in clinical investigation for collecting the highest level of evidence due to limit all sorts of bias. It is the most direct area where biostatistics applies in healthcare section. The aim of this module is to provide students an opportunity to gain sufficient knowledge on design and analysis of clinical trials using appropriate statistical approaches.
A Demonstrate an in-depth knowledge of principles, designs, and classifications of clinical trials B Perform appropriate statistical analyses on clinical trials with different types of endpoints and interpret the results C Understand how to carry out randomization and sample size calculation D Acquire an in-depth knowledge of statistical considerations for different designs of clinical trials E Acknowledge standard operating procedures on how to collect, manage, and report clinical trials’ data F Analyze safety data from a clinical trial
The module is delivered through a combination of lectures and tutorials over a period of 13 weeks. In lectures, students are introduced to the core principles, major methodology, and common topics in the area of trial design and analysis. Tutorials are given as a platform to address any specific question or issue from individual students.