Sydney West Translational Cancer Research Centre
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Masterclass in Clinical Trials: Conduct and Methodology

Organised by the NHMRC Clinical Trials Centre



Pullman Hyde Park, Sydney

This masterclass consists of two modules: 1. Clinical trials conduct (17−18 October)  2. Clinical trials methodology (19−20 October)

The course combines two 2-day courses which encompass a complete introduction to clinical trials. There will be information sessions and interactive small group workshops throughout the 4 days. Participants will have the opportunity to learn from presenters who are academic researchers and also to gain insights into the conduct of clinical trials from the other participants in the practical workshops.

There will also be an opportunity to interact with the presenters during the welcome reception (Monday 17 October), and 'Meet the professor' drinks (Wednesday 19 October).

Who should attend?
This course is aimed at staff involved in clinical trials management and investigators wishing to improve in or gain knowledge on aspects of clinical trials operations, design, methods, conduct and interpretation.

Course content:

Clinical trials conduct (17-18 October)

•Project management principles applied to clinical trials
•How to develop your idea into a study protocol
•An overview of the ethical and regulatory climate in Australia
•Data capture systems and processes to ensure quality and completeness
•Risk based monitoring and audit in clinical trials
•Personalised medicine in clinical trials, e.g. biomarker and translational research
•Incorporating patient-reported outcomes (PROs) into clinical trials

Clinical trials methodology (19-20 October)

•Rationale and designs including biomarker-driven designs
•Outcomes and generalisability
•Sample size and power
•Comparing groups
•Concepts of multiplicity
•Interim analysis and stopping rules
•Noninferiority/equivalence design
•Composite/co-primary outcomes

Workshop faculty
The workshop faculty based at the Clinical Trials Centre have extensive experience and expertise in the development and management of clinical trials, teaching clinical trials methods, and statistical design and analyses.

Registration Fees:

Registration type

Early bird rate (before 30 June) Standard rate (after 30 June)
2-day Clinical trials conduct $990 $1320
2-day Clinical trials methodology $990 $1320
4-day Clinical trials conduct and methodology $1650 $1980

Course inclusions
Course fees include a course manual, morning and afternoon refreshments and lunch. A certificate of attendance will be provided to participants who complete a course.