PLEASE NOTE: This course has had a change of code and title - up to and including 2009, the course code was PHPH9120. Up to and including 2016, the course title was Clinical Development of Medicines.

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.

Note: This course is one of two options for the compulsory Clinical Trials component for programmes 5371 and 9370.