Postgraduate - UnitEPM5007 - Design of randomised controlled trials

This unit entry is for students who completed this unit in 2014 only. For students planning to study the unit, please refer to the unit indexes in the the current edition of the Handbook. If you have any queries contact the managing faculty for your course or area of study.

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6 points, SCA Band 2, 0.125 EFTSL

Refer to the specific census and withdrawal dates for the semester(s) in which this unit is offered, or view unit timetables.

Level	Postgraduate
Faculty	Faculty of Medicine, Nursing and Health Sciences
Organisational Unit	Department of Epidemiology and Preventive Medicine
Offered	Alfred Hospital Second semester 2014 (Off-campus)
Coordinator(s)	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.

Outcomes

On completion of this unit, students will be able to:

Identify the benefits of randomisation as a mechanism for reduction and balancing bias, and implement a variety of randomisation schemes.
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
Describe the efficiency advantages of crossover designs, and be able to design, analyse and interpret the two-period crossover study.
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
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)

Professor Andrew Forbes

Workload requirements

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.