Clinical Trial Design

10 Units

Introduces randomised controlled trials and the reasons why they are considered the gold standard in modern medical research. Important statistical issues such as randomisation, the intention to treat principle and sample size are covered in detail.

Faculty Faculty of Health and Medicine
School School of Medicine and Public Health
Availability Semester 2 - 2017 (Distance Education - Callaghan)
Learning Outcomes

On successful completion of this course, students will be able to:

  1. Understand the importance of randomisation and utilise a range of randomisation schemes;
  2. Understand the difference between, and implications of, per protocol analysis, as treated analysis and intention to treat analysis;
  3. Demonstrate knowledge of different clinical trial designs and their advantages and disadvantages;
  4. Understand the difference between phase I, II, III and IV clinical trials;
  5. Recognise the role pre-trial sample size calculations have in clinical trials and perform these calculations for a range of trial designs.

This course introduces a variety of basic randomised controlled trial designs that are employed in medical research and discusses the merits and drawbacks of each design in the context of clinical practice. The importance of randomisation and reporting standards are developed as well as methods for estimating the required sample size before the trial is conducted.




  • Must be in G Dip Medical Biostatistics or M Medical Statistics. Pre-requisites: must have successfully completed BIOS6040 and EPID6420. Anti-requisite: This course replaces BIOS6060. If you have completed BIOS6060 you cannot enrol in this course.
Assessment Items
  • Written Assignment: Essays / Written Assignments

Contact Hours Not currently offered
Timetable 2017 Course Timetables for BIOS6061
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