Advanced Clinical Trials

Course code BIOS6141
Not available in 2015

Description

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).

Availability

Not currently available.

Learning Outcomes

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.

Content

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.

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

Self-Directed Learning

Self-Directed 6 hour(s) per Week for Full Term

As a guide only, students should anticipate spending 8-10 hours per week on study.