BIOSTATS 6013EX - Advanced Clinical Trials

External - Semester 2 - 2014

This elective unit extends and enhances the concepts developed in Design of Experiments and Randomised Controlled Trials. On completion, students have the knowledge and skills required at an advanced professional level to design and analyse clinical trials, including cross-over designs and equivalence trials, and to identify and implement statistical methods for monitoring and reporting, with appropriate knowledge of regulatory requirements. Topics to be covered include: methods in RCTs for determining stopping rules for interim analyses (O'Brien-Fleming, Peto), spending functions, stochastic curtailment; statistical principles encountered in relation to aspects of regulatory guidelines (ICH, HAD, EMEA), and related to reports prepared for data safety and monitoring committees (DSMC); design and analysis of cross-over trials (period effects, interactions); equivalence and non-inferiority trials; and problems of defining and using surrogate endpoints as alternatives to direct clinical outcomes.

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Course Details

Course Code	BIOSTATS 6013EX
Course	Advanced Clinical Trials
Coordinating Unit	Public Health
Term	Semester 2
Level	Postgraduate Coursework
Location/s	External
Units	3
Contact	Nil
Prerequisites	BIOSTATS 6000EX, BIOSTATS 6001EX, BIOSTATS 6003EX, BIOSTATS 6004EX, BIOSTATS 6005EX & BIOSTATS 6006EX
Restrictions	Available to Grad Cert, Grad Dip, M Biostatistics students only
Assessment	3 written assignments (25%, 25%,10%), at-home exam 40%

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Course Timetable

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Learning Outcomes

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Course Grading

Grades for your performance in this course will be awarded in accordance with the following scheme:

M10 (Coursework Mark Scheme)
Grade	Mark	Description
FNS		Fail No Submission
F	1-49	Fail
P	50-64	Pass
C	65-74	Credit
D	75-84	Distinction
HD	85-100	High Distinction
CN		Continuing
NFE		No Formal Examination
RP		Result Pending

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