2020-21 Course structure
Learning objectives of the course
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 specific aims of the course are:
- To provide in-depth training in, and understanding of, the principles and practices of conducting randomised clinical trials.
- To provide a forum for the nurturing of future global leaders in clinical trials in cardiovascular medicine and beyond.
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.
- 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 in vulnerable populations.
- Design to Implementation covers writing a protocol and developing a budget, project management, site selection, set-up and training, efficient recruitment and follow-up, appropriate monitoring, pharmaco-vigilance, outcome gathering and adjudication and opportunities for methodological innovation.
- Data Management and Analysis covers the use of online data collection packages, statistics for trials, sample size estimation, central statistical monitoring, data monitoring committees, analysis and the use of CDISC and SDTM.
- Big Data and New Technologies covers the use of electronic health records and registries for efficient recruitment, follow-up and data collection and the role of new types of electronic monitoring.
- Different Types of Trial in Particular Populations covers trials of devices, surgery, diagnostic strategies and complex interventions, trials within trials, trials in difficult circumstances and vulnerable populations and cluster randomised trials, deciding value-for-money of different trial designs.
- Health Economics and Patient Reported Outcome Measures covers the basics of health economic analyses of clinical trials, financial planning, use of various patient reported health-related quality of life measures and other patient reported measures.
- Meta-analyses (statistical foundations) and the Reporting of Trial Results covers how to report results of a clinical trial and to understand the statistical aspects of meta-analysis and understand its role, including various visual representations of the data.
Our MSc in Global Health Science and Epidemiology offers a greater statistical and epidemiological base if you are interested in this area of study.
Teaching is delivered during all six terms of the course and the vacation periods after the terms through 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 the residential periods. All students are allocated to a tutor group of five to six students.
In addition to the eight assessed modules, a number of masterclasses are organised throughout the course.