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Unit of study_
BSTA5006: Design of Randomised Controlled Trials (DES)
2025 unit information
The aim of this unit 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. This unit covers: 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.
Unit details and rules
Managing faculty or University school:
Medicine and Health
| Study level | Postgraduate |
|---|---|
| Academic unit | Public Health |
| Credit points | 6 |
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Prerequisites:
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(PUBH5010 or BSTA5011 or CEPI5100) and (BSTA5100 or BSTA5023) |
|---|---|
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Corequisites:
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None |
| Prohibitions:
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None |
| Assumed knowledge:
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None |
At the completion of this unit, you should be able to:
- LO1. Identify the benefits of randomisation as a mechanism for reducing bias, and implement a variety of randomisation schemes
- LO2. Demonstrate knowledge of the principles behind the common experimental designs
- LO3. Describe the efficiency advantages of crossover designs, and be able to design and interpret the two-period crossover study
- LO4. 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
- LO5. Appreciate the importance of sample size in clinical studies, and perform sample size calculations for a variety of trial designs with different outcomes
Unit availability
This section lists the session, attendance modes and locations the unit is available in. There is a unit outline for each of the unit availabilities, which gives you information about the unit including assessment details and a schedule of weekly activities.
The outline is published 2 weeks before the first day of teaching. You can look at previous outlines for a guide to the details of a unit.
| Session | MoA ? | Location | Outline ? |
|---|---|---|---|
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Semester 2 2025
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Online | Camperdown/Darlington, Sydney |
Outline unavailable
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Modes of attendance (MoA)
This refers to the Mode of attendance (MoA) for the unit as it appears when you’re selecting your units in Sydney Student. Find more information about modes of attendance on our website.
