Design of Randomised Controlled Trials

Postgraduate | 2026

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Area/Catalogue
BIOL 5028
Course ID icon
Course ID
203054
Level of study
Level of study
Postgraduate
Unit value icon
Unit value
6
Course level icon
Course level
5
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Inbound study abroad and exchange
Inbound study abroad and exchange
The fee you pay will depend on the number and type of courses you study.
No
University-wide elective icon
University-wide elective course
No
Single course enrollment
Single course enrolment
No
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Note:
Course data is interim and subject to change

Course overview

The aim of this course 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. 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 learning outcomes

  • See Studies Guides at: https://url.au.m.mimecastprotect.com/s/jyzMCmO5QMCjMl1XJtJi1URPVES?domain=bca.edu.au/
  • Identify the benefits of randomisation as a mechanism for reducing bias, and implement a variety of randomisation schemes.
  • Demonstrate knowledge of the principles behind the common experimental designs.
  • Describe the efficiency advantages of crossover designs, and be able to design and interpret the two-period crossover study.
  • Demonstrate an understanding of the principles underlying Phase I, II, 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, subgroup analyses and the handling of missing data.
  • Appreciate the importance of sample size in clinical studies, and perform sample size calculations for a variety of trial designs with different outcomes.

Prerequisite(s)

N/A

Corequisite(s)

N/A

Antirequisite(s)

N/A