It can be easy to feel positive about clinical trials if one thinks of it as a healthy person taking a calculated risk for the benefit of other sick people. Risk is involved in many aspects of day to day life. However, even if there is an element of this involved in clinical trials, they are still heavily regulated and the primary concern of every party is the safety of the volunteers.
In many ways, taking part in clinical trials can be a rewarding altruistic experience much like becoming an organ or blood donor.
A lot is known about the medicine that makes it to the clinical trial stage. In fact one of the misconceptions about these trials is precisely the belief that this is a new and unknown compound. Clinical trials involve medicine that has already been studied for many years. Trials are based on decades of research which is not difficult to access.
Strict Guidelines and Ethics
Clinical trials also have strict guidelines and ethics to consider when they are being designed. Only healthy volunteers can take part in these trials. Therefore, a medical “screening visit” must be taken before being accepted on the trial and it is possible to be denied entry if you do not meet the health conditions.
Trials can only be participated in one at a time. If you have taken part in a clinical trial recently, then you must wait three months from the end of the trial. Then you take another screening test.
In most cases smoking will be allowed (in a designated area) on a trial, but some trials may prohibit this and other substance use throughout the duration.
Trials are specifically designed to test certain groups and sexes. Healthy males aged 18-55, post-menopausal women, elderly men and children with certain conditions are just some of the groups that can be selected to take part in a clinical trial.
The Purpose of Clinical Trials
The main purpose of the clinical trial is to carry out testing of drugs before they are licensed and made available for prescription by health professionals. Clinical trials are usually done in the very last stages of drug development after significant work has been done by professionals in science, medicine and many other disciplines.
Volunteers are also generally paid up to £100 to cover their travel expenses to and from the Clinical Research Unit (CRU).
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This article was written by Nick Davison, of Covance Clinical Research Leeds.