By David Kerr, Kirstine Knox, Diane Robertson, Derek Stewart, Renee Watson
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Additional resources for Clinical Trials Explained: A Guide to Clinical Trials in the NHS for Healthcare Professionals
The guidelines are based on historical use and clinical trial evidence and determine what is considered current standard treatment. Standard treatments and diagnostics are those used ﬁrst for patients with disease; it does not indicate how effective the treatment will be. For example, the standard treatment for the most common form of bacterial meningitis is very effective if given early; however, if the infection is not diagnosed early, other treatments may need to be used. r An ‘inactive’ form of the treatment or placebo.
This is a perfectly valid reason for participating in a clinical trial. In a blinded trial, patients may come to think that they have been randomised to the control group receiving standard treatment or to the placebo group receiving an inactive form of the treatment, and therefore choose to withdraw. They may think this because of the way they are feeling, by comparing notes with other patients or by information gained from talking to members of the clinical trial team. In an unblinded trial, the patients know if they have been assigned to the control or placebo group, and can therefore choose to withdraw on the basis of this information.
For example it was recently discovered that a commonly used drug increased the risk of cardiovascular disease in certain patients. The drug, Vioxx, was also being tested in a large worldwide clinical trial called VICTOR for a disease it had not been used for before. Vioxx was withdrawn from the market and the clinical trial team was given the conﬁdential computer code to reveal patient assignments in the trial groups. Patients receiving Vioxx were notiﬁed immediately so that they could stop taking the medication and be checked for any side effects.