BIOS6061

Design of Randomised Controlled Trials

10 Units

Introduces randomised comparisons as a major tool used in medical research and the basis of providing evidence for improving clinical practice. Major topics are Randomised Controlled Trials; Issues in Randomised Controlled Trials; and Sample size. This course is offered in conjunction with the Biostatistics Collaboration of Australia (BCA).

Faculty Faculty of Health and Medicine
School School of Medicine and Public Health
Availability Semester 2 - 2014 (Distance Education - Callaghan)
Semester 2 - 2015 (Distance Education - Callaghan)
Objectives

On completion of this unit, students will be able to:

  1. Identify the benefits of randomisation as a mechanism for reduction and balancing bias, and implement a variety of randomisation schemes.
  2. Demonstrate knowledge of the principles behind the common experimental designs.
  3. Describe the efficiency advantages of crossover designs, and be able to design and interpret the two-period crossover study.
  4. Demonstrate an understanding of the principles underlying Phase I , II and III and IV studies as well as an appreciation of the scientific basis underlying issues in clinical studies including intention-to-treat, blinding, interim analyses and subgroup analyses.
  5. Appreciate the importance of sample size in clinical studies, and perform sample size calculations for a variety of trial designs with different outcomes
Content

This course will provide problems based on clinical questions, and the need and value of different experimental designs will be introduced and expanded. Within this context, issues with regard to randomisation, clinical study design and analysis interpretation will be developed. Efficiency issues such as sample size and power will be introduced at appropriate points in the unit.

Replacing Course(s) This course will replace the existing BCA course BIOS6060 (Design of Experiments & Randomised Clinical Trials). There are no other similar courses currently offered by other programs and therefore no further impact on other Faculties/Departments.
Transition This is a new course so transition arrangements are not required.
Industrial Experience 0
Assumed Knowledge Epidemiology (EPID6420); Mathematical Background for Biostatistics (BIOS6040)
Modes of Delivery Distance Learning : Paper Based
Teaching Methods Self Directed Learning
Assessment Items
  • Essays / Written Assignments - Assignments 100% (Two written assignments worth 30% and one assignment worth 40%)
Contact Hours
  • Self Directed Learning: for 6 hour(s) per Week for Full Term
Compulsory Components None listed
Course Materials None listed
Timetable 2015 Course Timetables for BIOS6061

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