Learning outcomes

Clinical Trials part aims (1) to discuss the ethical issues involved and how these affect the statistical methodology and (2) to introduce the specialist methods required. Topics covered include: controlled and uncontrolled clinical trials; protocol, placebo, randomization, blind and double blind trials, ethical issues, protocol deviations; size of clinical trials, interim analyses multi-centre trials, combining trials; Binary responses, logistics modelling.

The aim of Survival Analysis part is to provide a flavour of the statistical methodology developed for such problems, especially with regard to the handling of censored data. Topics covered include: survivor function, hazard function, censoring; clinical life tables, Kaplan-Meier survival estimators, parametric models; comparisons of two groups -log rank test; inclusion of covariates, Cox's proportional hazards model.

Contents

Content of Clinical Trials: The special ethical and regulatory constraints involved in experimentation on human subjects mean that Clinical Trials have developed their own distinct methodology, although the fundamentals of mainstream statistical theory are recognisable.

Content of Survival Analysis: Prediction of survival times or comparisons of survival patterns between different treatments are examples of great importance in medical statistics.

Teaching language

English

Evaluation

Numeric 1-5.

Recommended year of study

2. year autumn
2. year spring
3. year autumn
3. year spring

Belongs to following study modules