Design of Randomised Controlled Trials
Subject POPH90119 (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 |
| Prerequisites: | - Subject Study Period Commencement: Credit Points: |
| Corequisites: | None |
| Recommended Background Knowledge: | None |
| Non Allowed Subjects: | None |
| Core Participation Requirements: | None |
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.
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| 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
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| 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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