The module will reinforce what students have learnt about clinical trials on the Epidemiology, Statistics and Research Methods module and will explore the key practical and scientific issues in greater depth. This module aims to provide students with a theoretical and practical understanding of trial methodology with a focus on understanding, critical appraisal and interpretation of published work. Materials will be derived from real, ongoing or completed, trials, systematic reviews and meta-analyses.The course will primarily involve task-based learning and facilitated group-discussion.
Learning Outcomes
By the end of the module the student should be able to:
1. Understand the role of randomised trials and be able to explain the purpose of randomisation.
2. Understand the processes of ethical approval, trial management, data and safety monitoring, informed consent, data protection, Good Clinical Practice and regulation as applied to clinical trials
3. Recognise and understand the principles of good trial design, conduct, analysis and reporting and be able to critically appraise and interpret trial results.
4. Understand how trial results can be used in meta-analysis to help evaluate clinical effectiveness and safety and in cost-effectiveness analyses to inform health policy.
A relevant skills test delivered as coursework (up to 2,500 words) during the semester (50%) and a face to face closed book examination of 2 hours (50%).
Reassessment:
Resubmission / resit of failed components, i.e. one or both of relevant skills test delivered as coursework (up to 2,500 words) during the semester (50%) and a face to face closed book examination of 2 hours (50%).
