Design of experiments and clinical trials (6 points)
(MED)
Leader: Dr V. Gebski
Offered:
Clayton Second semester 2004 (OCL)
Clayton Second semester 2005 (OCL)
Synopsis:
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
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