Taking part in a clinical trial

Before deciding if you want to take part in a clinical trial, your doctors will tell you about the treatment you will have and what you will have to do during the trial.

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 and your name won’t be used when the results are published.

Information and giving consent

Before you go into a trial, a doctor, nurse or other researcher will ask for your permission. They can’t enter you into the trial if you don’t give your written consent, after you have had plenty of time to think about it.

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

  • what the trial is trying to find out
  • what the trial will involve and what you’ll have to do.

There are guidelines for researchers that explain what information people need to help them decide whether to take part in a clinical trial. But there’s a lot of discussion about how much people really want to know, and this varies from person to person.

It’s important that you have enough information to make an informed decision. You should feel able to ask any questions that will help you to make a decision. Before you decide, you should also feel that you have been given enough time to think about the trial and what it will mean to you.

Someone from your medical team will be able to answer any questions you may have. They will go through the possible benefits and risks of joining the trial. 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.

You will be given a patient information leaflet about the trial. You can take this away and read it in your own time before you are formally invited to take part.

If you decide to take part

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’ll then be asked to sign a consent form that says that you agree to take part. Your doctor will also sign the consent form. You’ll be given a copy to keep.

If you decide not to take part

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 the hospital staff treat you, and you’ll be offered the standard treatment for your type of cancer.

Find out all the information you can, ask as many questions as you can, and do make the decision that’s right for you.

Wendy


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.

Remember that you can pull out of the trial at any stage. You have to trust that it won’t compromise your care, although I do understand that concerns people.

Ben


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’re in a trial as they’re 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 co-ordinating the trial may look at your records 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.

Current trials for DCIS

There are usually different trials for DCIS. Your specialist can tell you whether any are suitable for you.