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Unit of study_

CLTR5001: Introduction to Clinical Trials

2024 unit information

This unit of study will focus on the strengths and weaknesses of different clinical study designs. Designs considered will include cohort (retrospective and prospective), cross-sectional, case-control and randomized controlled designs. The different phases of clinical trial designs in the development of therapies will also be examined including phase I (first in man), phase II/pilot and phase III comparative designs. Extension and adaptation of randomized designs will also be covered including cluster and factorial designs and adaptive pilot studies. Students will gain the skills necessary to choose between these designs for best practice. Types of outcomes (continuous, categorical, time-to-event) will be discussed. Methods of allocating participants to interventions (randomization), as well blinding and allocation concealment will be covered together with aspects of protocol development. On completion of this unit, the student will be familiar with the differences between study types and study designs, as well as the principles and practice of randomisation. It is also expected that the candidate will be able to develop stratified randomisation schemes for their own studies.

Unit details and rules

Managing faculty or University school:

NHMRC Clinical Trials Centre

Code CLTR5001
Academic unit NHMRC Clinical Trials Centre
Credit points 6
Assumed knowledge:

At the completion of this unit, you should be able to:

  • LO1. understand which phase and/or type of study is required to address the primary question of any trial
  • LO2. understand basic statistical concepts of a trial design, such as sample size calculations and randomisation
  • LO3. understand the basic principles of protocol design and the key aspects that go into it
  • LO4. understand the different study designs (observational and experimental), the advantages and disadvantages of each, and when they are appropriate to use
  • LO5. understand the different types of study outcomes
  • LO6. understand how outcomes relate to study design
  • LO7. understand basic principles for sample size calculations
  • LO8. understand outcomes which are specific to oncology studies
  • LO9. understand the purpose, design and analysis, and interpretation of phase 1 and 2 clinical trials (including dose-finding)
  • LO10. show a basic understanding of phase 3 trials
  • LO11. understand the rationale for phase 4 clinical trials
  • LO12. understand the rationale for and the principle of phase 3 studies and RCTs
  • LO13. understand different study designs (parallel, crossover, etc.) and when they would be appropriate to use
  • LO14. understand the difference between superiority, non-inferiority and equivalence studies
  • LO15. understand the theory behind basic methods of randomisation and why randomisation is important
  • LO16. understand the role of less common approaches to randomisation
  • LO17. understand the important of blinding and the different types
  • LO18. understand methods of allocation concealment
  • LO19. understand the basic format, importance and purpose of a protocol
  • LO20. understand how the topics in this unit relate to the sections of a protocol.

Unit availability

This section lists the session, attendance modes and locations the unit is available in. There is a unit outline for each of the unit availabilities, which gives you information about the unit including assessment details and a schedule of weekly activities.

The outline is published 2 weeks before the first day of teaching. You can look at previous outlines for a guide to the details of a unit.

Session MoA ?  Location Outline ? 
Semester 1 2024
Online Camperdown/Darlington, Sydney
Outline unavailable
Session MoA ?  Location Outline ? 
Semester 1 2020
Online Camperdown/Darlington, Sydney
Semester 1 2021
Online Camperdown/Darlington, Sydney
Semester 1 2022
Online Camperdown/Darlington, Sydney
Semester 1 2023
Online Camperdown/Darlington, Sydney

Modes of attendance (MoA)

This refers to the Mode of attendance (MoA) for the unit as it appears when you’re selecting your units in Sydney Student. Find more information about modes of attendance on our website.

Important enrolment information

Departmental permission requirements

If you see the ‘Departmental Permission’ tag below a session, it means you need faculty or school approval to enrol. This may be because it’s an advanced unit, clinical placement, offshore unit, internship or there are limited places available.

You will be prompted to apply for departmental permission when you select this unit in Sydney Student.

Read our information on departmental permission.