2023-24 Course structure
The MSc in Clinical Trials aims to provide a thorough understanding of the theoretical underpinning and practical aspects of randomised clinical trials and an in-depth training in trials methodology. The course will cover different types of trials and clinical conditions with an emphasis on large, streamlined clinical outcome trials in cardiovascular disease.
The curriculum comprises eight compulsory modules of varying length and intensity across six terms and vacation periods.
- An Introduction to the Principles of Randomised Trials covers the benefits of randomisation, the role of trials in research, the role of epidemiology, refining the question, choosing outcomes and good trials design.
- Design to Implementation covers writing a protocol, project management, site selection, set-up and training, efficient recruitment and follow-up, appropriate monitoring, pharmaco-vigilance, the use of online data collection packages, outcome gathering and adjudication and opportunities for methodological innovation.
- Data Management and Analysis covers statistics for trials, sample size estimation, central statistical monitoring, data monitoring committees, different methods of analysis and the use of CDISC and SDTM.
- The Regulatory and Ethical Framework and Participant Involvement covers how to obtain approvals, informed consent processes, appropriate interpretation of ICH Good Clinical Practice guidelines and relevant regulations, the importance of public engagement and the ethics of trials including in vulnerable populations.
- Routine Health care Data, Big Data and New Technologies covers the use of electronic health records and registries for efficient recruitment, follow-up and data collection and how new technologies (such as different types of biological sensors) can be used for trial monitoring or outcome measures.
- Health Economics for Clinical Trials and Patient Reported Outcomes covers the basics and principles of health economic analysis for clinical trials, including relevant data collection methods and use of various patient reported health-related quality of life measures and other patient reported measures.
- Meta-analyses and Trial Reporting covers how to report results of a clinical trial including various visual representations of the data. Also how to understand the statistical aspects and role of meta-analysis of trials.
- Different Types of Trials and Populations
Our MSc in Global Health Science and Epidemiology offers a greater statistical and epidemiological base if you are interested in this area of study.
Throughout the course teaching is delivered using a range of methods including online lectures, seminars, workshops and student presentations, as well as self-directed learning and independent study. The teaching will all be online, with the exception of two residential periods, in September and March of year 2. All students are allocated to a seminar group of eight to ten students.