When deciding whether to take part in a clinical trial, you should be clear about the purpose of the clinical trial and what is expected of you. You need to consider the following fully before you enrol in a clinical trial;
You will be cared for by doctors and nurses with detailed knowledge about the latest treatments for your condition.
You will be monitored very closely during the trial and may benefit from additional testing that would not normally be carried out in routine clinical practice.
You will be given the opportunity to be one of the first patients to benefit from the new treatment under investigation; if you are not responding well to current therapies, participation in a clinical trial may give you access to a treatment that will work better for you.
However, you may experience unexpected side effects to the new treatment and/or it may not be an effective treatment for you. The new drug may prove to be less effective than current available treatments.
Close monitoring of the trial may result in more frequent hospital visits and more testing than would occur if you were not on the clinical trial. This could be disruptive to your life.
You should discuss any concerns or issues you have regarding your health and care during the clinical trial with your doctor before enrolling. It is very important to be fully informed about the purpose of the clinical trial, potential benefits and side effects of taking the new treatment, and what is expected of you in terms of hospital visits and tests during the clinical trial.
Phase III clinical trials usually compare a new treatment with either current treatment or a placebo or dummy treatment. It is important to remember that in these clinical trials treatments are randomly allocated and usually neither you nor your doctor will know which treatment you are on until the end of the trial. You or your doctor will not be able to choose which treatment you receive. At the end of the trial, if you were receiving the least effective treatment you might be given the opportunity to switch to the more effective treatment; your doctor will discuss this with you.
For participation in a clinical trial you will always be asked to sign a consent form to indicate your agreement to take part and that you are fully informed about the treatment under investigation and what is expected of you during the trial. You have the right to withdraw from a clinical trial at any time, and you do not have to give an explanation. Your care at the hospital or clinic will not be affected in any way and you will be offered current, existing treatment for you condition.
All information collected during a clinical trial, including your personal details and case notes, will be kept strictly confidential. The organisation responsible for analysing and reporting the results of the trial will identify your test results and details by a number and your initials only.
In the following video, Clare, a clinical trial participant openly shares her experiences. She shares her thoughts on her decision to participate in a randomised clinical trial, her experiences with the consent form and the issues she considered when joining the trial. She is candid in her discussions. She gives us the opportunity to reflect on the options presented by being a part of a randomised clinical trial.
Watch ‘One patient’s perspectives about participating in a randomised clinical trial’ here