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Unit of study_

Design of Randomised Controlled Trials - BSTA5006

Year - 2018

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.

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

Assessment
3 written assignments (30%, 30%, 40%)

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

Pre-requisites

BSTA5001 and (BSTA5011 or PUBH5010)

Details

Faculty: Medicine and Health

Semester 2

30 Jul 2018

Department/School: Public Health
Study Mode: Distance education
Census Date: 31 Aug 2018
Unit of study level: Postgraduate
Credit points: 6.0
EFTSL: 0.125
Available for study abroad and exchange: No
Faculty/department permission required? No
Location
Camperdown
More details
Unit of Study coordinator: Professor Judy Simpson
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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