Monash University Handbook 2010 Postgraduate - Unit

Level	Postgraduate
Faculty	Faculty of Medicine, Nursing and Health Sciences
Offered	Alfred Hospital Second semester 2010 (Off-campus)
Coordinator(s)	Associate Professor P Ryan

Synopsis

This unit will introduce randomised comparisons as a major tool used in medical
research and the basis of providing evidence for improving clinical practice. By
developing problems based on clinical questions, the need and value of different
experimental designs will be introduced and expanded. Within this context, issues
with regards 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.

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, subgroup analyses and
the reporting thereof

5. Appreciate the importance of sample size in clinical studies, and perform sample size

calculations for a variety of trial designs with different outcomes

Assessment

Written Assignments (100%)

Chief examiner(s)

Associate Professor Peter Ryan

Contact hours

Off campus students:
Twelve hours per week, consisting of (on average) 4 hours per week for reading core
material, 4 hours per week completing exercises (manual, computer-based, or on-line), 2 hours per week for on-line communication with teaching staff or students via WebCT, and 2 hours per week for assignment preparation. No residential component is required for this subject.

Prerequisites

EPM5002 and MPH1040

Prohibitions

This unit is only available to students enrolled in the Graduate Certificate, Graduate Diploma or Masters of Biostatistics.

Additional information on this unit is available from the faculty at:

http://www.med.monash.edu.au/epidemiology/pgrad