By David Kerr, Kirstine Knox, Diane Robertson, Derek Stewart, Renee Watson
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Extra info for Clinical Trials Explained: A Guide to Clinical Trials in the NHS for Healthcare Professionals
Although the randomised controlled trial in which both the clinical trial team and the patients are blinded is the gold standard in clinical research, this type of trial may not always be possible or even preferable. For example, clinical trials: r May be gathering preliminary data to see if a treatment is safe enough to warrant a full-scale trial and may have no control group; r May be examining a treatment for a serious condition that has no alternative treatment, and randomisation would be unethical.
It is important Questions about Clinical Trials 43 for the clinical trial team to know why a patient has withdrawn so they can account for what happened to all patients involved and assess the effects of the intervention on all patients enrolled. Patients withdraw from a clinical trial for a number of reasons, the most common reasons include: r Fear of being randomised to the control group – even though the main purpose of a clinical trial is to advance medical knowledge in a way that will beneﬁt future patients, the main reason most people enter a trial is the hope that they may improve their health.
Information about the sex and age of participants and medical characteristics is often included, but nothing identiﬁes an individual. 40 Chapter 5 If something goes wrong, will the patient receive compensation? Yes. The diagnostic tests and treatments used in clinical trials conform to the highest standards. Commercial organisations manufacturing the diagnostics or treatments are insured so that if a patient is damaged by some unforeseen event, compensation can be paid. It is rare for patients to be harmed in this way, although in some drug trials the trial participants may suffer unpleasant side effects.