Handbook

Clinical Trials pertains to the design, development, safe conduct and interpretation of trials for therapeutic products in humans.  This course is designed to provide students with the skills to interpret the clinical literature, understand Good Clinical Practice (GCP) and clinical development and give students the skills to design and analyse clinical trials from first time in man Phase I through to Phase II, III and IV trials and registries. The course examines the importance of  pharmacokinetic, pharmacodynamic and pharmacogenomic studies in humans. Adaptive clinical trial designs are also examined. Novel clinical trial endpoints such as surrogate endpoints and biomarkers will be discussed.  Trial designs for different types of therapeutic products will be examined, as will the ethics of clinical trials.