The aim of this unit is to enable students to understand and apply the principles of design and analysis of experiments, with a particular focus on randomised controlled trials (RCTs), to a level where they are able to contribute effectively as a statistician to the planning, conduct and reporting of a standard RCT. This unit covers: ethical considerations; principles and methods of randomisation in controlled trials; treatment allocation, blocking, stratification and allocation concealment; parallel, factorial and crossover designs including n-of-1 studies; practical issues in sample size determination; intention-to-treat principle; phase I dose-finding studies; phase II safety and efficacy studies; interim analyses and early stopping; multiple outcomes/endpoints, including surrogate outcomes, multiple tests and subgroup analyses, including adjustment of significance levels and P-values; missing data; reporting trial results and use of the CONSORT statement.
8-12 hours total study time per week, distance learning
3 written assignments (30%, 30%, 40%)
Matthews JNS. Introduction to Randomised Controlled Clinical Trials, 2nd edition. Chapman and Hall/CRC Press 2006. ISBN P/back: 978154886242, eBook: 9781420011302
BSTA5001 and (BSTA5011 or PUBH5010)