Advanced Clinical Trials

Subject POPH90138 (2010)

Note: This is an archived Handbook entry from 2010.

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

This subject has the following teaching availabilities in 2010:

Semester 2, Parkville - Taught online/distance.
Pre-teaching Period Start not applicable
Teaching Period not applicable
Assessment Period End not applicable
Last date to Self-Enrol not applicable
Census Date not applicable
Last date to Withdraw without fail not applicable


Timetable can be viewed here. For information about these dates, click here.
Time Commitment: Contact Hours: None
Total Time Commitment: 8-12 hours total study time per week
Prerequisites: -
Study Period Commencement:
Credit Points:
Semester 1, Semester 2
Semester 1, Semester 2
Semester 1, Semester 2
Semester 2
Corequisites: None
Recommended Background Knowledge: None
Non Allowed Subjects: None
Core Participation Requirements: None


Prof John Carlin


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.

Objectives: This elective subject extends and enhances the concepts developed in Design of Experiments and Clinical Trials (505-939). 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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