Children's Cancer and Leukaemia Group
Clinical Trials
Introduction to Clinical Trials

References

There are many books and training courses available on the subject of clinical trials. The following are recommended as good general introductions.

'Clinical Trials: A Practical Approach' by Stuart Pocock. Pub. Wiley, 1983

'Data Management and Clinical Trials: EORTC Study Group on Data Management' Ed. N. Rotmensz (now out of print)

'Cancer Clinical Trials: Method and Practice'. Ed. M.E. Buyse, M.J. Staquet and R.J. Sylvester. Pub. Oxford Medical Publications.

  1. Introduction
  2. What is a Clinical Trial?
  3. Clinical Trial procedure
  4. The role of the Chief Investigator
  5. The Protocol
  6. How is the size of a clinical trial determined?
  7. What is a multi-centre trial?
  8. Role of coordinating centre/Trials Unit
  9. What is randomisation?
  10. How is a patient randomised for a particular trial?
  11. What is a control in clinical trials?
  12. Forms and data management
  13. Statistics in clinical trials
  1. The role of the trial coordinator
  2. Follow up
  3. How is the trial data analysed/evaluated?
  4. What are pharmacokinetic studies?
  5. Ethical issues
  6. Conduct of Clinical Trials/Research
  7. What is a blind trial?
  8. Interpretation and publication of findings
  9. Survival Curves
  10. CCLG Protocols – development and approval process
  11. References
  12. Download PDF