Module code: MD7451
Module co-ordinator: Keith Abrams
This module will provide an outline of the principles of clinical trial design and conduct, with reference to the basic ideas of general experimental design and how these principles are modified and restricted in practice. Special problems of analysis and interpretation of clinical trials results will be reviewed. Introductory experience in designing clinical trials and interpreting their results will illustrate the principles. The role and importance of statistical techniques covered later on the MSc will be discussed in the context of clinical trial design, analysis and interpretation.
Introduction to Clinical Trials
- What is a clinical trial?
- When and why are they necessary?
- Different types of trial. Ethical issues.
- Trial protocols. Blindness.
- Planning the trial: formulation of hypotheses.
- Explanatory and pragmatic approaches: clinical trials as hypothesis testing and decision procedures.
- Choice of outcome measures and implications for analysis.
- Selecting patient populations and samples.
- Obtaining and maintaining comparable patient groups: selection, allocation and assessment biases and their avoidance .
- Allocation to treatment: simple, restricted and stratified randomisation; minimisation.
- Legal and Research Governance Issues in Clinical Trials. (External speaker)
- Extensions: cluster randomised trials, crossover trials, equivalence trials, factorial trials and meta-analysis.
- Sample size determination: fixed and adaptive methods; brief introduction to sequential designs.
- Introduction to Phase 2 Designs. (External speaker)
- Trial Critiques
Clinical Trials Project
This project gives the student experience in analysing a randomised controlled trial. It uses a real dataset, which inevitably comes with some real problems. It is the first opportunity on the course to carry out an extended piece of analysis and to write up a formal scientific report. There will be an introductory session at the start and then three support sessions during the project along with a discussion board on the VLE.
Advanced Clinical Trials
Aspects of clinical trials are considered including:
- Drug regulatory perspectives on clinical trial design, conduct, analysis and interpretation
- Design and analysis issues in crossover trial designs
- Design and analysis issues in cluster trial designs
- Meta-analysis of clinical trial data
- Inclusion of economic evaluation in or with trial designs
- An introduction to personalised medicine
These sessions are delivered by experienced researchers, internal and external, working in the area.
- 25 one-hour lectures
- Five one-hour seminars
- 24 one-hour workshops
- Problem-based exercises (10%)
- Mini-project (60%)
- Coursework (30%)