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Clinical Trials

Ethical issues

Every clinical trial requires careful assessment of whether it is ethically acceptable for patients to participate. Ethical considerations should be of continuing concern throughout the design and conduct of the trial. For the conduct of clinical trials in the UK, there is a very thorough process of both national and local Ethical Committee approval, designed to ensure protection of the patient. All clinical trials need to have their protocol approved by such a committee before the trial commences. The ethical committee approval places considerable emphasis on informed patient, or parent, consent.

The safety and wellbeing of the patient are paramount and must always take precedence over science and research.

>>>> Conduct of Clinical Trials/Research >>>>

  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. UKCCSG Protocols – development and approval process
  11. References
  12. Download PDF
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