Dr Sara Brookes (course organiser), Professor Alan Montgomery, Dr Chris Metcalfe, Dr Athene Lane, Dr Ceire Costelloe, Dr Birgit Whitman, Professor Tim Peters, Dr Jeremy Horwood, Professor Will Hollingworth, Dr Jelena Savovic.
15-19 June 2015
The aim of the course is to provide an understanding of key issues in the design, analysis and reporting of clinical trials. The course focuses on randomised controlled trials in the evaluation of healthcare technologies. Observational epidemiological study designs, including cross-sectional, cohort and case-control studies, are not covered in this course.
By the end of the course, students should:
Anyone involved in the design, conduct, analysis or reporting of a randomised trial in the academic or NHS sector. Students will be expected to have a knowledge of statistical methods up to the level of the Basic Statistics course, and an understanding of research design up to the level of the Basic Epidemiology course. Basic knowledge of Stata is preferable but not essential.
Topics to be covered include: the need for clinical trials; planning issues; pragmatic and explanatory trials; hypothesis testing; clinical and statistical significance; sample size; randomisation; cluster trials; intention to treat analysis; alternative trial designs; multiple outcomes; adjustment for covariates; subgroup analysis; CONSORT guidelines on trial reporting; qualitative methods in clinical trials; feasibility studies, health economics in the context of clinical trials; ethical issues in trials.
Teaching will make up a total of thirty hours, consisting of interactive-type lectures and problem-based learning in small groups.
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