Curriculum
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.
COORDINATORS:
General outline
Prerequisites
Epidemiology, Mathematical Foundations for Biostatistics
Time commitment
8-12 hours total study time per week
Semester availability
Semester 2
Assessment
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 softwareContent
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.
Resources
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.
