Advanced Clinical Trials and Prospective Observational Studies

Course code BIOS6141
Not available in 2017


This course introduces more advanced concepts in designing and analysing clinical trials and prospective observational studies.


Not currently available.

This Course was last offered in Semester 2 - 2017.

Learning Outcomes

On successful completion of the course students will be able to:

1. Understand the basic theoretic and applied principles of clinical trials and prospective observational studies;

2. Analyse clinical research data using SAS software;

3. Design an interim analysis with early stopping rules;

4. Check underlying model assumptions;

5. Impute missing data using the EM algorithm;

6. Compute sample size and power for advanced clinical research designs;

7. Prepare publication-ready summary tables and write-up of results.


Conducting sound clinical research is a foundational pillar of medicine. Students will be exposed to modern methods for conducting clinical research.  Topics presented will include: Futility analysis, stochastic curtailment, group sequential methods, Lan-Demets alpha-spending function, O’Brien-Fleming bounds, computation of conditional power, gatekeeper methods, sequential monitoring, missing by design biomarker clinical trials, equivalence and non-inferiority trials, imputation using the EM algorithm, power analysis for multiple endpoint studies, fuzzy-set and propensity score matching algorithms for observational studies, sources of and methods for handling non-randomisation bias, closed-testing and permutation procedures for multiplicity adjustment, sacrificial matched-set designs, alternative surrogate endpoints for primary clinical endpoints, cross-over trials, stepped wedge trials, multiple baseline studies, block randomisation with random block sizes, adaptive 2-stage clinical trials, cluster randomisation, and tests for trend and dose response.  




This course replaces BIOS6140. If you have successfully completed BIOS6140 you cannot enrol in this course.

Assessment Items

Written Assignment: Essays / Written Assignments

Contact Hours