All patients who participate in clinical trials are volunteers and can choose to stop their involvement at any time and still receive the best treatment available for their condition.
A doctor or nurse may ask you if you would like to take part in a clinical trial if they think you are eligible for the trial and they think it will benefit you.
Some patients also do their own research to find a clinical trial they hope to take part in. If you find a trial you think you are eligible for, please talk to your doctor as you can only join a clinical trial by a referral from your doctor.
The research team
The clinical trial research team includes lots of different people but you will probably meet:
The team may also include research fellows (scientists), data managers and clinical trial coordinators, although you may not meet any of these people.
During a trial, you are likely to have the most contact with your nurse. Their role is to coordinate your care while you are on the trial. This includes organising investigations, taking blood samples and giving drug treatments.
The nurse will provide you with information about the trial and answer any questions you may have along the way. They are there to support both you and your family.
Information and consent
If you are asked to take part in a clinical trial, you need to be given enough information to help you make up your mind as to whether or not to participate. Taking part in a clinical trial is completely your choice and your care will not be affected if you choose not to join the trial.
All patients taking part in a trial must complete a process called informed consent to make sure that they understand what the trial involves and what the trial is trying to find out.
The doctor and research nurse will provide you with a patient information sheet and give you time to discuss the trial with your family and friends and ask any questions you may have before you decide whether you would like to take part.
If you wish to participate in a clinical trial after learning about all that is involved, and what you would be expected to do, then you will be asked to sign the informed consent form, agreeing to join the trial.
The informed consent process does not end once you sign the form. You will be asked if you are happy to remain on the trial at each visit with your clinician or care team. If new benefits, risks or side effects are found during a trial, the doctor must inform all the participants in the trial.
Patients always have the option to withdraw their consent and stop taking part. If you decide you do not want to continue to take part at any time, simply tell your doctor or research nurse. You do not need to provide a reason for not taking part and your treatment will change to receiving the standard treatment for your cancer.
Screening
Not everyone will be eligible for a particular clinical trial, even if you have the type of cancer that the new treatment is aiming to treat.
Every trial has a protocol that sets out a detailed plan that is carefully designed to safeguard the health and safety of the participant. It identifies the things you need to have to take part in the trial and the things that rule you out of the trial. These could include the stage of cancer, genetic requirements, your age or the types of treatment you have had before.
Your medical records will be compared to all the requirements in the protocol and you may have to have some further tests to make sure you are eligible to join the trial.
Enrolment
If you pass the screening process and you still wish to proceed, you will be enrolled in the trial by the research team.
There will be some paperwork to complete, including the informed consent form. By enrolling in a clinical trial you are agreeing to share your medical information with the research team while you are on the trial and in follow-up.
Your information will be stored in a database along with data from all the other participants in a way that you cannot be personally identified. This data will used to analyse whether the new treatment is delivering the results the trial set out to test.
Taking part
Clinical trials can run for anything from a few months to several years. During that time you may need to go into hospital or to a clinic regularly to receive the treatment, or you may be able to take it at home.
You will be monitored for any side effects and asked to fill in questionnaires or answer questions when you go for treatment.
Your health and safety are the most important consideration for the whole time you are taking part in the trial. You must tell your doctor or nurse if you are having any problems with the new treatment or are feeling unwell.
After the trial treatment finishes you will continue to be monitored and checked to see if there are any long-term effects following the trial.
Results
After the trial is finished it can take quite a long time for the researchers to analyse the data and come up with the results. The findings will usually be written up as a paper and published in an academic journal. These papers tend to be written for a medical audience so can be very technical.
Your research team will be able to help you understand the results and what they mean for you and other cancer patients. Often the results will lead to further research studies but certainly every piece of information gained from a clinical trial will help build our knowledge of cancer treatment.