Advanced Clinical Trials

Subject POPH90138 (2013)

Note: This is an archived Handbook entry from 2013.

Credit Points: 12.50
Level: 9 (Graduate/Postgraduate)
Dates & Locations:

This subject is not offered in 2013.

Time Commitment: Contact Hours: None
Total Time Commitment:

8-12 hours total study time per week



Study Period Commencement:
Credit Points:
Not offered in 2013
Semester 2


Recommended Background Knowledge:


Non Allowed Subjects:


Core Participation Requirements:

For the purposes of considering request for Reasonable Adjustments under the Disability Standards for Education (Cwth 2005), and Students Experiencing Academic Disadvantage Policy, academic requirements for this subject are articulated in the Subject Description, Subject Objectives, Generic Skills and Assessment Requirements of this entry.
The University is dedicated to provide support to those with special requirements. Further details on the disability support scheme can be found at the Disability Liaison Unit website.


Professor Val Gebski, University of Sydney
Biostatistics Collaboration of Australia


Academic Programs Office
Melbourne School of Population Health
Tel: +61 3 8344 9339
Fax: +61 3 8344 0824

Subject Overview:

Methods in RCTs for determining: stopping rules for interim analysis (O’Brien-Fleming, Peto), spending functions, stochastic curtailment; statistical principles encountered in relation to aspects of regulatory guidelines (ICH, FDA, EMEA), and related to reports prepared for data safety and monitoring committees (DSMC); design and analysis of cross-over trials (period effects, interactions); equivalence and non-inferiority trials; problems of defining and using surrogate endpoints as alternatives to direct clinical outcomes.


This elective subject extends and enhances the concepts developed in Design of Experiments and Clinical Trials (POPH90119). On completion of this subject, students have the knowledge and skills required at an advanced professional level to design and analyse clinical trials, including cross-over designs and equivalence trials, and to identify and implement statistical methods for trial monitoring and reporting, with appropriate knowledge of regulatory requirements.


Three written assignments to be submitted during semester, two worth 25% each (approx 8 hrs work each) and one worth 10% (approx 6 hrs work).

One end of semester at-home examination worth 40% (approx 12 hours)

Prescribed Texts:

Recommended Texts:

Jennison, C. and Turnbull, B.W. Group Sequential Methods with Applications to Clinical Trials 1999, Chapman & Hall. (ISBN 978-0849303166)

Senn S. Cross-over Trials in Clinical Research, 2nd edition 2002, Wiley. (ISBN 978-0471496533).

Breadth Options:

This subject is not available as a breadth subject.

Fees Information: Subject EFTSL, Level, Discipline & Census Date
Generic Skills:

Independent problem solving, facility with abstract reasoning, clarity of written expression, sound communication of technical concepts

Links to further information:

This subject is not available in the Master of Public Health.

Related Course(s): Master of Biostatistics
Postgraduate Certificate in Biostatistics
Postgraduate Diploma in Biostatistics

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