Design of Randomised Controlled Trials (DES)

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.

A/Prof Lynne Giles University of Adelaide, School of Public Health Semester 2
General outline


Epidemiology, Mathematical Foundations for Biostatistics

Time commitment

8-12 hours total study time per week

Semester availability

Semester 2


Assignments 100% (three written assignments, the first two worth 30% each and the final assignment worth 40%

Prescribed Texts

Matthews JNS, Introduction to Randomized Controlled Clinical Trials, 2nd edition, Chapman and Hall 2006

Special Computer Requirements

R or Stata software


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 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.


Course notes, online mini-lecture videos, online tutorials, discussion board

The BCA acknowledges we live and work on the ancestral lands of Aboriginal and Torres Strait Islander peoples, who have for thousands of generations exchanged knowledge for the benefit of all. We pay our respects to those who have cared and continue to care for Country.