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.
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: | ||||||||||||
Corequisites: | None | ||||||||||||
Recommended Background Knowledge: | None | ||||||||||||
Non Allowed Subjects: | None | ||||||||||||
Core Participation Requirements: | None |
Coordinator
Prof John CarlinContact
Professor Val Gebski, University of Sydney
Biostatistics Collaboration of Australia
OR
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 |
Download PDF version.