Design of Randomised Controlled Trials


Introduces randomised comparisons as a major tool used in medical research and the basis of providing evidence for improving clinical practice. Major topics are Randomised Controlled Trials; Issues in Randomised Controlled Trials; and Sample size. This course is offered in conjunction with the Biostatistics Collaboration of Australia (BCA).


Distance Education - Callaghan

  • Semester 2 - 2015

Learning Outcomes

1. Identify the benefits of randomisation as a mechanism for reduction and balancing bias, and implement a variety of randomisation schemes.

2. Demonstrate knowledge of the principles behind the common experimental designs.

3. Describe the efficiency advantages of crossover designs, and be able to design and interpret the two-period crossover study.

4. Demonstrate an understanding of the principles underlying Phase I , II and III and IV studies as well as an appreciation of the scientific basis underlying issues in clinical studies including intention-to-treat, blinding, interim analyses and subgroup analyses.

5. Appreciate the importance of sample size in clinical studies, and perform sample size calculations for a variety of trial designs with different outcomes


This course will provide problems based on clinical questions, and the need and value of different experimental designs will be introduced and expanded. Within this context, issues with regard to randomisation, clinical study design and analysis interpretation will be developed. Efficiency issues such as sample size and power will be introduced at appropriate points in the unit.

Replacing Course(s)

This course replaces the following course(s): BIOS6060. Students who have successfully completed BIOS6060 are not eligible to enrol in BIOS6061.

Assumed Knowledge

Epidemiology (EPID6420); Mathematical Background for Biostatistics (BIOS6040)

Assessment Items

Written Assignment: Essays / Written Assignments

Contact Hours

Distance Education - Callaghan

Self-Directed Learning

Self-Directed 6 hour(s) per Week for Full Term

Suggest 8-12 hours per week time commitment (guide only).