This course introduces more advanced concepts in designing and analysing clinical trials and prospective observational studies.
Not currently offered.
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.
Written Assignment: Essays / Written Assignments