Topics addressed during the course:
1 - Basic concepts and designs
Controlled and uncontrolled clinical trials; historical controls; protocol; placebo; randomisation; blind and double blind trials; ethical issues; protocol deviations. Ethical considerations. Specialist medical journals and web facilities.
2 - Basic Trial Analyses
Outline of parallel and in series group designs, cross-over, factorial and sequential designs.
3 - Randomisation
Rationale, simple, blocking, unequal allocation, stratification, minimisation methods.
4 - Size of trials
Power and sample size calculations for simple two sample tests, facilities in R and illustration of Web-based facilities.
5 - Multiplicity
Problems of multiple end-points, interim analyses, subgroup analyses etc.
6 - Cross-over trials
Two period two group crossover trials, tests for carry-over and period and treatment effects.
7 - Binary response data
Mantel-Haenszel and McNemar's tests, relative risks, odds ratios and outline of logistic regression modelling.
Controlled and uncontrolled clinical trials; historical controls; protocol; placebo; randomisation; blind and double blind trials; ethical issues; protocol deviations. Ethical considerations. Specialist medical journals and web facilities.
2 - Basic Trial Analyses
Outline of parallel and in series group designs, cross-over, factorial and sequential designs.
3 - Randomisation
Rationale, simple, blocking, unequal allocation, stratification, minimisation methods.
4 - Size of trials
Power and sample size calculations for simple two sample tests, facilities in R and illustration of Web-based facilities.
5 - Multiplicity
Problems of multiple end-points, interim analyses, subgroup analyses etc.
6 - Cross-over trials
Two period two group crossover trials, tests for carry-over and period and treatment effects.
7 - Binary response data
Mantel-Haenszel and McNemar's tests, relative risks, odds ratios and outline of logistic regression modelling.