Statistical Principles and Clinical Trials (CLTR5007)


Statistical principles and concepts required to design clinical trials and analyse trial results will be introduced, including the appraisal of the appropriateness of analyses appearing in previous trial reports. Concepts which will be developed include an introduction to hypothesis testing, confidence interval estimation and understanding of univariable and adjusted analyses. Students will undertake analyses of study data where outcomes are continuous, binary and time-to-event variables Concepts and issues involved in performing landmark analyses and in identification of key prognostic variables and their interpretation in a clinical trials context will be introduced. The basis for and understanding of sample size calculations for clinical trials 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.

Our courses that offer this unit of study

Further unit of study information


discussion groups and problem based learning


2x quizzes (2x10%), 2xwritten assignments (2x40%)


Recommended readin: 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?


Unit of study rules



Study this unit outside a degree

Non-award/non-degree study

If you wish to undertake one or more units of study (subjects) for your own interest but not towards a degree, you may enrol in single units as a non-award student.

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.