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 - 2018 (Online)
Semester 1 - 2018 (Online)
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.




Assessment Items
  • Written Assignment: Essays / Written Assignments

Contact Hours


Self-Directed Learning

Self-Directed 6 hour(s) per Week for Full Term
Suggest 8-12 hours per week time commitment (guide only).

Timetable 2018 Course Timetables for BIOS6061
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