EPM5007 - Design of randomised controlled trials - 2018

6 points, SCA Band 2, 0.125 EFTSL

Postgraduate - Unit

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


Medicine, Nursing and Health Sciences

Organisational Unit

Department of Epidemiology and Preventive Medicine

Chief examiner(s)

Professor Andrew Forbes


Dr Amy Salter

Unit guides


Alfred Hospital


EPM5002, MPH5040.


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


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.


Upon successful completion of this unit, students 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.


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.

See also Unit timetable information

This unit applies to the following area(s) of study

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