Advanced Clinical Trial Design

Clinical trials are designed to test new methods of screening, prevention, diagnosis and treatment of disease and are essential to discovering whether new healthcare interventions improve outcomes for patients. This subject will provide students a theoretical and practical understanding of the issues involved in the design, conduct, analysis and interpretation of clinical trials, in particular the randomized controlled trial (RCT), and will build on the concepts introduced at the graduate certificate level. Fundamental concepts associated with the design, implementation and analysis of RCTs will be explored including selecting, recruiting and consenting study subjects, determination of study duration, comparing multiple groups and/or endpoints, designing randomisation protocols, study monitoring, quality assurance and early termination.