Taking part in a clinical trial

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 and answer your questions. They should be able to 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 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 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, 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? Back to top

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 Back to top

Remember that even if you give your consent to a trial, you can leave it without giving a reason at any time. 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.

Confidentiality Back to top

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 tissue samples for future research Back to top

Many blood samples and bone marrow or tumour biopsies may be taken to diagnose your cancer, and during your treatment. 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. You won’t normally be told the results of any tests on these samples.

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.