This course covers: Ethics in Practice; Interpretation of Clinical Trials: Statistics; Health Economics, Medicines Regulation and Good Clinical Practice; and Research Governance.

Lectures, tutorials and practical classes in S2.

Exam (75%)

Coursework (25%) - A short (1,500-2,000 word) case study of an ethical issue in clinical research

The aim of this course is to provide students with an in-depth understanding of new drug discovery and safe translation and evaluation in man. Subsequent processes of registration, approval and introduction to clinical practice provide insights into safe drug development and more effective therapeutic strategies.

By the end of the course the student should be able to:

■ identify and apply ethical considerations of drug development and clinical trials,

■ describe and evaluate national and international approaches to new drug registration and approval,

■ critically discuss the rationale and delivery of Good Clinical Practice in clinical research

■ recognise and plan strategies to monitor drug use, safety and efficacy, in long-term clinical practice.

Students must submit at least 75% by weight of the components (including examinations) of the course's summative assessment.