Postgraduate - UnitEPM5007 - Design of randomised controlled trials

This unit entry is for students who completed this unit in 2015 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.

Level	Postgraduate
Faculty	Faculty of Medicine, Nursing and Health Sciences
Organisational Unit	Department of Epidemiology and Preventive Medicine
Offered	Alfred Hospital Second semester 2015 (Off-campus)
Coordinator(s)	Dr Amy Salter

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, ethical issues, clinical study design and analysis interpretation will be developed, as will selection of outcome variables, surrogate endpoints and dealing with missing data. Efficiency issues such as sample size and power will be introduced at appropriate points in the unit.

Outcomes

Upon successful completion of this unit, students should be able to:

Identify the benefits and ethical issues involved in randomisation as a mechanism for reduction and balancing bias, and implement a variety of randomisation schemes.
Describe the principles behind the common experimental designs and be able to implement, analyse and interpret data from a variety of randomised designs.
Describe the advantages and disadvantages of the use of surrogate endpoints.
Describe the principles underlying Phase I, II and III and IV studies as well as of the scientific basis underlying issues in clinical studies including intention-to-treat, blinding, interim analyses, missing data subgroup analyses and the reporting thereof.
State the reasons for 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%)

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.