BIOS6060

Design of Experiments & Randomised Clinical Trials

10 Units 6000 Level Course

Not available in 2014

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

Introduces randomised comparisons as a major tool used in medical research and the basis of providing evidence for improving clinical practice. Major topics are Experimental Design and Analysis; Randomised Controlled Trials; Issues in Randomised Controlled Trials; and Sample size. The course will be offered in distance learning mode only.

Objectives On completion of this unit, students will be able to:
1. Identify the benefits of randomisation as a mechanism for reduction and balancing bias, and implement a variety of randomisation schemes.
2. Demonstrate knowledge of the principles behind the common experimental designs and be able to implement, analyse and interpret data from a variety of randomised designs.
3. Describe the efficiency advantages of crossover designs, and be able to design, analyse and interpret the two-period crossover study.
4. Demonstrate an understanding of the principles underlying Phase I , II and III and IV studies as well as an appreciation of the scientific basis underlying issues in clinical studies including intention-to-treat, blinding, interim analyses and subgroup analyses.
5. Appreciate the importance of sample size in clinical studies, and perform sample size calculations for a variety of trial designs with different outcomes
Content This course will provide problems based on clinical questions, and the need and value of different experimental designs will be introduced and expanded. Within this context, issues with regard to randomisation, clinical study design and analysis interpretation will be developed. Efficiency issues such as sample size and power will be introduced at appropriate points in the unit.
Replacing Course(s) N/A
Transition N/A
Industrial Experience 0
Assumed Knowledge Epidemiology, and Mathematical Background for Biostatistics.
Modes of Delivery Distance Learning : Paper Based
Teaching Methods Self Directed Learning
Assessment Items
Essays / Written Assignments Assignments 100% (Two written assignments worth 30% each, one assignment worth 40%)
Contact Hours Self Directed Learning: for 6 hour(s) per Week for Full Term
Compulsory Components
Requisite by Enrolment This course is only available to students enrolled in the Graduate Diploma in Medical Statistics or Master of Medical Statistics programs.