Clinical Trials

Module code: MD7451

Module Outline

This module will provide an outline of the principles of clinical trial design and conduct. The role and importance of statistical techniques will be discussed in the context of clinical trial design, analysis and interpretation. Special problems of analysis and interpretation of clinical trials results will be reviewed.

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.

Advanced Clinical Trials

The role and importance of statistical techniques will be discussed in the context of clinical trial design, analysis and interpretation. Special problems of analysis and interpretation of clinical trials results will be reviewed. Topics covered include:

  • Drug regulatory perspectives on clinical trial design, conduct, analysis and interpretation
  • Design and analysis issues in crossover trial designs and 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.

Learning

  • 14 one-hour lectures
  • 10 hours of practicals
  • 4 hours of project supervision
  • 122 hours of independent study

Assessment

  • Written report (60%)
  • Problem based exercises (40%)