Design of Randomised Controlled Trials

BSTA5006

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: 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, multiple tests and subgroup analyses, including adjustment of significance levels and P-values; reporting trial results and use of the CONSORT statement.

Unit of study details

Unit of study level: Postgraduate

Credit points: 6

Commencing semesters: 2

Further unit of study information

Unit of study handbook: BSTA5006

Costs and scholarships information: Costs and Scholarships

Final dates to withdraw from units of study: Census Dates

Available for study abroad and exchange: No

Our courses that offer this unit of study