This module covers the development of a new medicine from early exploratory clinical development right through to the stage of applying for a licence for marketing. We will highlight practical issues associated with running clinical trials, including large-scale multinational projects.
Key topics include: Clinical trial design, clinical end points, writing a protocol, project management, ethical and legal aspects of clinical research, logistics issues in clinical trials, clinical trials in children, data gathering for phase 2-4 studies, adverse events in clinical trials. You will take part in workshop sessions and practical exercises to “develop” a new molecule and learn how to apply the principles of statistics to clinical trial design.
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