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Semester 2 - Online
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Topics include: 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 analysis 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.
Intended learning outcomes
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.
Independent problem solving, critical appraisal of research literature, clarity of written expression, sound communication of technical concepts
Last updated: 3 November 2022