Masterclass in clinical trials methodology and conduct
Monday 17 October–Thursday 20 October 2016
This masterclass consists of two modules:
1. Clinical trials conduct
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
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.
conduct (17-18 October)
methodology (19-20 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
- Data capture systems and processes to ensure quality and
- Risk based monitoring and audit in clinical trials
- Personalised medicine in clinical trials, e.g. biomarker and
- Incorporating patient-reported outcomes (PROs) into clinical
- 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
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.
(before 31 August)
(after 31 August)
|2-day Clinical trials conduct
|2-day Clinical trials methodology
|4-day Clinical trials conduct and methodology
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.
Venue and times
The course will be held at the Pullman Hyde Park, Sydney.
Registration will be open from 8:30 am, with a prompt start time of
8:50 am. Each day the approximate finishing time is 5 pm.
How to register?
Visit the secure online registration system
To visit our FAQ page, click here. Please direct any other
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