Design of Randomised Controlled Trials (BSTA5006)

UNIT OF STUDY

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

Classes

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

Assessment

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

Textbooks

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

Faculty/department permission required?

No

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.