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
Each patient is his or her own best protection against harm. Patients can do this by: r Fully disclosing to the trial doctor and research nurse medical history, current state of health and medication. It is important that patients make sure that their medical records are available to the trial doctors. Patients should conﬁrm that the research doctor and their other doctors are communicating about what is happening during the clinical trial and outside the trial in terms of any care received. g.
To determine whether the treatment is effective, the clinical trial team needs to subtract the impact of the placebo effect. When the control group is given a placebo (and the close medical monitoring that is part of the clinical trial), the placebo effect can be subtracted when the results of the experimental and control groups of the clinical trial are compared. In some clinical trials, the clinical trial team may want to compare the effects of the medical intervention and placebo in the same patient.
G. patients should let their doctors know that they are taking a vitamin C supplement to help a cold. It is the patient’s responsibility to be as honest and open as possible about any changes he or she makes for health, and the doctor’s responsibility to respect the patient’s decisions and take all things into consideration. For patients on a trial, it is very important to promptly 44 Chapter 5 report any side effects to the clinical trial team, even if they are not sure that the symptoms or side effects are related to the treatment; r Fully disclosing to the designated person, usually the trial doctor or nurse, anything the patient did that he/she was not supposed to do.