Advanced Clinical Trials

10 Units

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).

Faculty Faculty of Health and Medicine
School School of Medicine and Public Health

Not currently offered


On completion of this unit, students should 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 will replace the existing course Advanced Clinical Trials & Meta Analysis (BIOS6140). There are no other courses offered by other programs and therefore no impact on other Faculties/Departments.
Transition Not applicable.
Industrial Experience 0
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);
Modes of Delivery Distance Learning : Paper Based
Teaching Methods Self Directed Learning
Assessment Items
  • Essays / Written Assignments - Assignments 60%, examination 40%
Contact Hours
  • Self Directed Learning: for 6 hour(s) per Week for Full Term
Compulsory Components None listed
Course Materials None listed
Timetable 2015 Course Timetables for BIOS6141

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