Advanced Clinical Trials & Meta-Analysis

Course code BIOS6140Units 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).

Not available in 2014

Previously offered in 2011, 2010, 2009, 2008, 2007, 2006, 2005, 2004
ObjectivesOn completion students should:
1. have an advanced understanding of randomised controlled trials;
2. be able to design and analyse a wide variety of randomised control trials;
ContentThe first component of the course discusses methods in RCTs for determining stopping rules for interim analyses, spending functions, stochastic curtailment, analysis methods used with cross-over designs, preference outcomes, N-of-1 studies and equivalence, and non-inferiority trials. The second component discusses the statistical principles encountered in relation to aspects of regulatory/reporting guidelines, and relates to reports prepared for data safety and monitoring committees.
Replacing Course(s)N/A
Industrial Experience0
Assumed KnowledgeMathematical Background for Biostatistics;
Design of Experiments & RCTs;
Probability and Distribution Theory
Principles of Statistical Inference;
Linear Models;
*Survival Analysis
* Co-requisite - may be taken concurrently.
Semester availability:
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