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 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.

Special Computer Requirements

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