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

Distance

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:

Subject

Study Period Commencement:

Credit Points:

POPH90016 Epidemiology

Semester 1, Semester 2

12.50

POPH90015 Mathematics B'Ground for Biostatistics

Not offered in 2010

12.50

POPH90017 Principles of Statistical Inference

Semester 1, Semester 2

12.50

POPH90148 Probability and Distribution Theory

Semester 1, Semester 2

12.50

POPH90119 Design of Randomised Controlled Trials

Semester 2

12.50

POPH90120 Linear Models

Semester 2

12.50

Corequisites:

None

Recommended Background Knowledge:

None

Non Allowed Subjects:

None

Core Participation Requirements:

None

Coordinator

Prof John Carlin

Contact

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
Email: sph-gradinfo@unimelb.edu.au

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.
Assessment:	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:	http://www.sph.unimelb.edu.au
Notes:	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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