BIOS6061
10 units
6000 level
Course handbook
Description
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.
Availability2024 Course Timetables
Online
- Semester 2 - 2024
Learning outcomes
On successful completion of the course students will be able to:
1. Explain the importance of randomisation in the context of clinical trials
2. Propose and implement an appropriate randomisation scheme for a range of clinical trial designs
3. Describe the difference between the per protocol, as treated and intention to treat analyses
4. Demonstrate knowledge of the advantages and disadvantages of different clinical trial designs
5. Choose an appropriate trial design and provide a justification for that choice in clinical context
6. Explain the difference between superiority, non-inferiority and equivalence comparisons
7. Calculate the power and/or required sample size for a variety of clinical trial designs and comparisons
8. Assess the implications to sample size and analysis of going from an individually randomised design to a cluster randomised design
Content
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: Assignment 1
Written Assignment: Assignment 2
Written Assignment: Assignment 3
Contact hours
Semester 2 - 2024 - Online
Self-Directed Learning-2
- Self-Directed 10 hour(s) per week(s) for 13 week(s) starting in week 1
- Suggest 8-12 hours per week time commitment (guide only).
Course outline
Course outline not yet available.
The University of Newcastle acknowledges the traditional custodians of the lands within our footprint areas: Awabakal, Darkinjung, Biripai, Worimi, Wonnarua, and Eora Nations. We also pay respect to the wisdom of our Elders past and present.