How safe is it?
Clinical trials are carried out under the strict supervision of fully qualified doctors, nurses and other health professionals. All trials are run in accordance with European legislation and two government bodies must first approve all trials before any clinical procedures may commence. The two government bodies are the MHRA (Medicines and Healthcare Products Regulatory Agency) and a government authorised Research Ethics Committee. In order to give approval for the study to go ahead the MHRA experts will assess all applications for new medicines to ensure that they meet the required standards, and the Research Ethics Committee have specially trained members in research ethics and often have the sort of experience which will be useful in scrutinizing the ethical aspects of a research proposal. Members of a Research Ethics Committee will often include patients, members of the public, nurses, GPs, hospital doctors, statisticians, pharmacists and academics, as well as people with specific ethical expertise gained through a legal, philosophical or theological background.
Before every trial volunteers are given a full pack of information about the study to read through in detail and are able to spend as much time as required with one of the Research Doctors discussing all the details and potential risks of the study. This process is called informed consent and will be completed before any study procedures are able to take place. After the formal consenting session with the doctor you will be able to take the information home to discuss with friends, family and maybe even your GP. A consent form does not need to be signed until the participant feels that they have enough information to make the decision to take part, and even once the form is signed volunteers are able to withdraw their consent from a study at any time.
Before any volunteer can take part in a clinical trial, we take great care to ensure that you are suitable to do so. Volunteers are very carefully screened against the approved study protocol and are required to undergo a thorough medical examination, which includes taking blood samples for a variety of tests (including Hepatitis and HIV) as well as tracing your heart (ECG) and measuring your blood pressure. We will also contact your GP to check that there are no medical conditions in your history that might affect your participation, and we routinely make checks to ensure that previous studies that a volunteer may have completed at another site will not affect their participation in a study at PAREXEL. Only those volunteers meeting the strict criteria set for each study will be selected for participation and all volunteers included in the study are very closely monitored throughout the study for any potential side effects.
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