EPM5007

Design of experiments and clinical trials ( 6 points, SCA Band 2, 0.125 EFTSL)

Leader: Dr V. Gebski

Offered:
Clayton Second semester 2005 (OCL)
MMS-ALFRED Second semester 2005 (OCL)

Synopsis: This unit will introduce randomised comparisons as a major tool used in medical research and the basis of providing evidence for improving clinical practice. By developing problems based on clinical questions, the need and value of different experimental designs will be introduced and expanded. Within this context, issues with regards 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.

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 and be able to implement, analyse and interpret data from a variety of randomised designs; 3. describe the efficiency advantages of crossover design, and be able to design, analyse 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 and 5. appreciate the importance of sample size in clinical studies, and perform sample size calculations for a variety of trial designs with different outcomes.

Assessment: Three written assignments + Written examination

Prerequisites: EPM5002

Corequisites: EPM5003