Advanced Clinical Trials

Course code BIOS6141
Not available in 2016


This course will provide students with advanced knowledge and skills relating to randomised clinical trials. Students will be exposed to the statistical principles, issues and methods involved in the design and analysis of randomised controlled trials (RCTs). This course is offered in conjunction with the Biostatistics Collaboration of Australia (BCA).


Not currently available.

Learning Outcomes

On successful completion of the course students will be able to:

1. Design and analyse a group sequential trial based on commonly used stopping rules and error spending approach

2. Demonstrate knowledge of the regulatory issues and principles underlying the conduct of any clinical trial

3. Understand the basis for cross-over trials, their advantages and their pitfalls together with the way to analyse such trials.

4. Understand the principles underpinning an equivalence and a non-inferiority trial

5. Appreciate issues associated with defining and using good surrogate endpoints as alternatives to primary clinical endpoints.


The course discusses methods in RCTs for determining stopping rules for interim analysis, analysis methods used with cross-over designs, equivalence, and non-inferiority trials, surrogate end points and the statistical principles encountered in relation to aspects of regulatory/reporting guidelines.

Replacing Course(s)

This course replaces the following course(s): BIOS6140. Students who have successfully completed BIOS6140 are not eligible to enrol in BIOS6141.


This course replaces BIOS6140. If you have successfully completed BIOS6140 you cannot enrol in this course.

Assumed Knowledge

Epidemiology (EPID6420); Mathematical Background for Biostatistics (BIOS6040); Design of Experiments & RCTs (BIOS6060) Probability and Distribution Theory (BIOS6170); Principles of Statistical Inference (BIOS6050); Linear Models (BIOS6070);

Assessment Items

Written Assignment: Essays / Written Assignments

Contact Hours