Taking part in a trial

Before deciding if you want to take part in a clinical trial, you will be given information about the treatment you will have and what you will have to do during the trial.

The person who suggested you take part in the trial will explain why they have suggested it. They will explain the potential benefits and risks of the trial, and give you information that you can take away and read in your own time. You should feel comfortable that you have all the information you need and feel able to ask any questions. You may want to talk to your family or friends about the trial before making a decision.

If you decide you want to take part in the trial, you will be asked to sign a consent form. You can’t be entered into a trial without giving your consent.

If you decide not to take part in the trial, you can tell your doctor or nurse. You don’t have to give a reason and, you will be offered the standard treatment for your type of cancer.

If you give your consent to take part in a trial and then change your mind, you can leave it at any time without giving a reason.

All your medical records are confidential. Your name will be removed from any samples you give for research and you will not be named when the results are published.

Deciding whether to take part in a clinical trial

Before you go into a trial, a doctor, nurse or other researcher will ask your permission. They can’t enter you into the trial if you don’t give your consent.

To help you decide whether you want to take part, the researchers should tell you:

  • what the trial is trying to find out
  • how you will be treated
  • what you will have to do.

Guidelines have been drawn up for researchers to tell them what information people need to help them decide whether to take part in a clinical trial. But there is a lot of discussion about how much people really want to know and this varies from person to person.

It’s important that you are satisfied that you have enough information to make an informed decision. You should feel free to ask any questions that you believe are important in helping you to reach a decision. You should also feel that you have been given enough time to think about the trial and what it will mean to you before you decide.

The person who suggested that you take part in the trial in the first place should discuss it with you. They will explain why they have suggested it and answer any questions you may have. They should be able to give you an idea of any possible benefits and potential risks of the trial, and give you a patient information leaflet or fact sheet about the trial that you can take away and read in your own time. They should also discuss any other treatments that may be appropriate in your situation. You may want to talk about it with your family or friends and think about any practical aspects, such as extra appointments and tests.

If you decide to take part in the trial

If you decide that you want to take part, you may be asked to give your consent verbally to the person carrying out the trial, who will write it in your notes. You will then be asked to sign a consent form that says that you agree to take part, and the form will be countersigned. You will be given a copy to keep.

If you decide not to take part in the trial

If you decide not to take part in the trial, you can tell your doctor or nurse. Your decision will be respected and you don’t have to give a reason. There will be no change in the way that you are treated by the hospital staff and you will be offered the standard treatment for your type of cancer.


Who is responsible for your care?

During the trial your cancer specialist and GP are still the people in charge of your care, making the day-to-day decisions with you about your treatment.


Withdrawing from a trial

Remember that even if you give your consent to a trial, you can leave it at any time without giving a reason. If you’re having a new treatment as part of a trial and then leave the trial, you may not be able to continue having the new treatment. In this situation you’ll be given the appropriate standard treatment for your type of cancer.

If you are thinking of leaving a trial it’s a good idea to discuss it with your specialist or your research nurse.


Confidentiality

If you agree to take part in a clinical trial, your GP will only be told if you give your consent. It can sometimes help for your GP to know you are in a trial as they are responsible for your day-to-day health at home. If you have any queries or problems during the trial, you should talk to the specialist doctor responsible for it, or your research nurse.

Your medical records concerning the trial are confidential. Sometimes a representative of a relevant drug company, or staff from the trials office who are coordinating the trial, may look at them to check that all the necessary information is collected accurately. No one who looks at your notes can give information to anyone outside the healthcare team looking after you. In the same way, when the results are published you will not be named.


Blood and tumour samples

Blood and tumour samples may be taken to help make the right diagnosis. You may be asked for your permission to use some of your samples for research into cancer. If you take part in a trial you may also give other samples, which may be frozen and stored for future use when new research techniques become available. Your name will be removed from the samples so you can’t be identified.

The research may be carried out at the hospital where you are treated, or at another one. This type of research takes a long time, and results may not be available for many years. The samples will be used to increase knowledge about the causes of cancer and its treatment, which will hopefully improve the outlook for future patients.


Back to Can and should I take part?

Questions to ask

You may like to ask your doctor or nurse some questions before deciding whether to take part in a clinical trial.