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Unit of study_

Design of Randomised Controlled Trials (DES) - BSTA5006

The aim of this unit is 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. This unit covers: ethical considerations; 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 analyses and early stopping; multiple outcomes/endpoints, including surrogate outcomes, multiple tests and subgroup analyses, including adjustment of significance levels and P-values; missing data; reporting trial results and use of the CONSORT statement.

8-12 hours total study time per week, distance learning

Assignments 100% (three written assignments, the first two worth 30% each and the final assignment worth 40%)

Matthews JNS. Introduction to Randomised Controlled Clinical Trials, 2nd edition. Chapman and Hall/CRC Press 2006. ISBN P/back: 978154886242, eBook: 9781420011302

Additional information
Special Computer Requirements: Nil - win_sam and PS software will be supplied by the unit coordinator


BSTA5001 and (BSTA5011 or PUBH5010)


Faculty: Medicine and Health

Semester 2

05 Aug 2019

Department/School: Public Health
Study Mode: Distance education
Census Date: 31 Aug 2019
Unit of study level: Postgraduate
Credit points: 6.0
EFTSL: 0.125
Available for study abroad and exchange: No
Faculty/department permission required? No
More details
Unit of Study coordinator: Associate Professor Patrick Kelly
HECS Band: 2
Courses that offer this unit

Non-award/non-degree study If you wish to undertake one or more units of study (subjects) for your own interest but not towards a degree, you may enrol in single units as a non-award student. Cross-institutional study If you are from another Australian tertiary institution you may be permitted to undertake cross-institutional study in one or more units of study at the University of Sydney.

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