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

Conduct of Clinical Trials/Research

Recommendations guiding medical doctors in biomedical research involving human subjects are contained in the Declaration of Helsinki, adopted by the World Medical Assembly in Helsinki in 1964, and updated subsequently.

Originally introduced in connection with pharmaceutical company trials the principles of Good Clinical Practice have now been adopted (to a greater or lesser degree) by all conducting clinical trials (ie both pharmaceutical companies and academia). The EU Directive on GCP in Clinical Trials, aimed at standardising trial conduct throughout Europe and effective from lst May 2004, brings an increasing level of regulatory requirements to the conduct of clinical trials, and represents the biggest single challenge faced by those working in the area of clinical trials.

>>>> What is a blind trial? >>>>

  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