By David Kerr, Kirstine Knox, Diane Robertson, Derek Stewart, Renee Watson

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Clinical Trials Explained: A Guide to Clinical Trials in the NHS for Healthcare Professionals Edited by Professor David J. Kerr, Dr Kirstine Knox, Diane C. Robertson, Derek Stewart, Renée Watson Copyright © 2006 by Blackwell Publishing Ltd CHAPTER 3 Clinical Trial Approval, Regulation and Funding Clinical trials are strictly regulated at all stages. This Chapter considers the steps that need to be taken and the organisations involved in getting the go ahead to run a clinical trial. The regulation of clinical trials is important to ensure that the trials that are run are scientifically valuable, are as safe as possible and have the greatest chance of improving patient care.

Such trials are also unethical if patients assigned to a placebo group would likely suffer serious harm compared to those receiving an experimental treatment. Further information on regulations can be found in Chapter 5. It is critically important to note that patients who receive a control – whether a standard intervention or a placebo – receive the same attention and followup as patients receiving the experimental treatment. The health of all patients in a clinical trial is carefully monitored by the doctors of the clinical trial team.

This process is based on the principle that people have the right to be informed of all the possible known benefits and risks of taking part in the trial, because they are considering volunteering for an experiment. This right is enshrined in UK law in line with international guidelines; further details on the legal framework within which clinical trials are conducted are given in Chapter 5. If a patient decides to take part in a clinical trial, he or she will be asked to sign a consent form and retain a copy.

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