BIOS6140

Advanced Clinical Trials & Meta-Analysis

10 Units 6000 Level Course

Not available in 2014

Previously offered in 2011, 2010, 2009, 2008, 2007, 2006, 2005, 2004

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).

Objectives On 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;
Content The 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
Transition N/A
Industrial Experience 0
Assumed Knowledge Mathematical 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 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