EPM5007 Design of randomised controlled trials
Faculty of Medicine, Nursing and Health Sciences
EPM5007 Design of randomised controlled trials is a level 5, 6-credit-point, postgraduate unit from the Faculty of Medicine, Nursing and Health Sciences, offered in 2023 in Semester 2 at Alfred Hospital. It needs EPM5002 and MPH5040 and unlocks 1 unit.
- Credit points
- 6
- Offered in 2023
- Semester 2
- Alfred Hospital
- Assessment
- No exam
- 1 task
This is the 2023 handbook entry. See the 2027 entry.
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Requisites
Before EPM5007
Prerequisites
Pass these before you enrol.
After EPM5007
1 unit list EPM5007 as a prerequisite or corequisite.
Enrolment rules
Overview
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.
Offerings in 2023
| Teaching period | Campus | Mode |
|---|---|---|
| Second semester | Alfred Hospital | De |
Assessment
- Written assignments100%
Learning outcomes
When you finish this unit, you should be able to:
- 1
Identify the benefits and ethical issues involved in randomisation as a mechanism for reduction and balancing bias, and implement a variety of randomisation schemes.
- 2
Describe 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 advantages and disadvantages of the use of surrogate endpoints.
- 4
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.
- 5
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.
Workload and teaching
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.
Learning resources
Required resources
See Moodle for details about required resources.
Contacts
- Chief Examiners
- Professor Andrew Forbes
Common questions
What are the prerequisites for EPM5007?
You need EPM5002 and MPH5040 before you enrol. Enrolment rules also apply.
What can I take after EPM5007?
EPM5007 is a prerequisite or corequisite for 1 unit, including EPM5006.
When is EPM5007 offered?
In 2023, EPM5007 runs in Semester 2 at Alfred Hospital.
Does EPM5007 have an exam?
No. EPM5007 has 1 assessment task and no exam.