Statistical Principles & Clinical Trials (CLTR5007)

UNIT OF STUDY

Statistical principles and concepts required to design, lead and manage clinical trials will be introduced, including the appraisal of the appropriateness of analyses appearing in previous trial reports. Concepts which will be developed include an understanding of simple and adjusted analyses. Students will undertake analyses of actual studies having outcomes which are continuous, binary and time-to-event including Kaplan-Meier and logrank tests. Concept and issues involved in performing landmark analyses will be introduced. Identification of key prognostic variables and their interpretation in a clinical trials context will be introduced. The basis for and understanding of detailed sample sized calculations for student's own trial proposals will be covered. Analyses will be performed using statistical software. SPSS and ACCorD software will be supported but students may use any package they are familiar with and have available. It is the student?s responsibility to purchase the software. Details will be given at the beginning of the semester.

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Further unit of study information

Classes

discussion groups and problem based learning

Assessment

2x quizzes (2x10%), 2x assessments (2x40%)

Textbooks

Interpreting and Reporting of Clinical Trials: a guide to the Consort statement. Other resources: Statistical package capable of performing sample size calculations and simple statistical procedures (e.g. Analysis of Censored and Correlated Data).

Faculty/department permission required?

No

Unit of study rules

Prerequisites and assumed knowledge

CLTR5001

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Cross-institutional study

If you are from another Australian tertiary institution you may be permitted to underake cross-institutional study in one or more units of study at the University of Sydney.

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