Advanced Clinical Trials

Course code BIOS6141Units 10Level 6000Faculty of Health and MedicineSchool of Medicine and Public Health

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 available in 2015

ObjectivesOn 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.
ContentThe 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.
TransitionNot applicable.
Industrial Experience0
Assumed KnowledgeEpidemiology (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 DeliveryDistance Learning : Paper Based
Teaching MethodsSelf Directed Learning
Assessment Items
Essays / Written AssignmentsAssignments 60%, examination 40%
Contact HoursSelf Directed Learning: for 6 hour(s) per Week for Full Term