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: 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.

Our courses that offer this unit of study

Further unit of study information


8-12 hours total study time per week, distance learning


3xwritten assignments (30%, 30%, 40%)


Piantadosi S. Clinical Trials: a Methodological Perspective, 2nd edition. Wiley 2005. ISBN 978-0-471-72781-1 Notes supplied

Faculty/department permission required?


Unit of study rules

Prerequisites and assumed knowledge

BSTA5001 and (BSTA5011 or PUBH5010)

Study this unit outside a degree

Non-award/non-degree study

If you wish to undertake one or more units of study (subjects) for your own interest but not towards a degree, you may enrol in single units as a non-award student.

Cross-institutional study

If you are from another Australian tertiary institution you may be permitted to underake cross-institutional study in one or more units of study at the University of Sydney.