Design of Experiments & Clinical Trials

Subject 505-939 (2008)

Note: This is an archived Handbook entry from 2008.Search for this in the current handbook

Credit Points: 12.500
Level: Graduate/Postgraduate
Dates & Locations:

This subject has the following teaching availabilities in 2008:

Semester 2, - Taught on campus.
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: 505-105 Mathematics Background for Biostatistics 505-106 Epidemiology
Corequisites: None
Recommended Background Knowledge: None
Non Allowed Subjects: None
Core Participation Requirements:

For the purposes of considering request for Reasonable Adjustments under the Disability Standards for Education (Cwth 2005), and Student Support and Engagement Policy, academic requirements for this subject are articulated in the Subject Overview, Learning Outcomes, Assessment and Generic Skills sections of this entry.

It is University policy to take all reasonable steps to minimise the impact of disability upon academic study, and reasonable adjustments will be made to enhance a student's participation in the University's programs. Students who feel their disability may impact on meeting the requirements of this subject are encouraged to discuss this matter with a Faculty Student Adviser and Student Equity and Disability Support: http://services.unimelb.edu.au/disability

Coordinator

Biostatistics Collaboration of Australia
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.

Subject 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, 1997 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

Level:500

Links to further information: http://www.sph.unimelb.edu.au
Notes:

This subject is not available in the Master of Public Health.

Coordinator: Assoc Prof Philip Ryan, Discipline of Public Health, University of Adelaide

Related Course(s): Master of Biostatistics
Postgraduate Certificate in Biostatistics
Postgraduate Diploma in Biostatistics

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