Design of Randomised Controlled Trials

Subject POPH90119 (2011)

Note: This is an archived Handbook entry from 2011.

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

This subject has the following teaching availabilities in 2011:

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:
Semester 1, Semester 2
12.50
Corequisites: None
Recommended Background Knowledge: None
Non Allowed Subjects: None
Core Participation Requirements: None

Coordinator

Prof John Carlin

Contact

Professor Phil Ryan, University of Adelaide
Biostatistics Collaboration of Australia
Email: bca@ctc.usyd.edu.au
Website: www.bca.edu.au

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:

Topics include: principles and methods of randomisation in controlled trials; treatment allocation, blocking, stratification and allocation concealment; parallel, factorial and crossover designs including n-of-1 studies; practical issues in sample size determination; intention-to-treat principle; phase I dose finding studies; phase II safety and efficacy studies; interim analysis and early stopping ; multiple outcomes/endpoints, multiple tests and subgroup analyses, including adjustment of significance levels and P-values; reporting trial results and use of the CONSORT statement.
Objectives: To enable students to understand and apply the principles of design and analysis of experiments, with a particular focus on randomised controlled trials (RCTs), to a level where they are able to contribute effectively as a statistician to the planning, conduct and reporting of a standard RCT.
Assessment: Three written assignments submitted during the semester; Two worth 30% each (approx 10 hours work each) and one worth 40% (approx 12 hours work).
Prescribed Texts: Piantadosi, S. Clinical Trials: A Methodological Perspective, 2nd ed, John Wiley & Sons, New York, 2005 (ISBN 978-0-471-72781-1)

Resources Provided to Students: Printed course notes and assignment material by mail, email, and online interaction facilities.
Breadth Options:

This subject is not available as a breadth subject.
Fees Information: Subject EFTSL, Level, Discipline & Census Date
Generic Skills:

Independent problem solving, critical appraisal of research literature, 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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