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Design of Randomised Controlled Trials - BCA807

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. 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.

Because of the multi-institutional nature of the BCA units, there is an early cut-off for enrolment in this unit. These dates are:
Session 1: 19 February 2018
Session 2: 23 July 2018

Credit Points: 4
When Offered:

S2 External - Session 2, External (On-campus sessions: None)

Staff Contact(s): Professor Gillian Heller
Prerequisites:

BCA801 and BCA802 Prerequisite Information

Corequisites:

NCCW(s):
Unit Designation(s):

Science

Assessed As: Graded
Offered By:

Department of Statistics

Faculty of Science and Engineering

Course structures, including unit offerings, are subject to change.
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