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10. Clinical Trials

A clinical trial is a research study, in which two or more groups of patients are given different treatments and the results compared.

Trials are used to investigate:

• New treatments for cancer;

• Different ways of giving care;

• Treatments used to relieve symptoms.

A trial may compare a new treatment with the best standard treatment currently available. Two methods of giving the same treatment may be tested against each other. Much of what is now accepted as standard treatment was tested in this way. Doctors rely on the results of clinical trials when they suggest or advise you about treatment.

Clinical trials have helped us make many advances in the diagnosis and treatment of breast cancer. Most of the newer drugs have been developed and introduced into everyday treatment as a result of such trials. Until recently the general term ‘research’ was used, so many people think these trials are new. (Clinical trials are one specific type of research.)

How will I know if I’m in a clinical trial?

By law, your doctor must tell you at the very beginning that the treatment option being recommended for you is being evaluated as part of a clinical trial or a research study. One of the questions you might like to ask your doctor is ‘Is this a trial?’ or ‘Is this a research

project?’ If any of the other staff caring for you, such as the nurses, are conducting a study of any kind you should also be informed.

Do I have to give my permission before I can be entered into a trial?

Yes. The staff running the trial must have your consent before they can do anything to you. You sign a consent form before an operation and many hospitals now ask for your written consent before some investigations, and before a course of radiotherapy or chemotherapy. You must agree to what the doctors, or other staff, propose before they can proceed. This is even more important if you are being asked to enter a clinical trial.

I’m thinking about taking part in a new drug trial. What should I know about the research?

There are several things you should be told, for example:

• What the trial involves;

• What benefits you may expect from it;

• What side effects might occur; and

• What it means to you in the way of extra tests or visits to hospital, and so on.

You will be given some written information and allowed time to decide whether or not to join the trial. There may be more questions you want to ask in order to understand what is planned. You should not give your consent until you are completely happy about the project.

There is a new drug trial which my doctor sounds keen on. I have read all the papers about it, but I’m not sure. What if I say no?

You have the right to say yes or no to any treatment which is suggested. If you do not wish to take part in a trial you should say so. It will not affect your current or future treatment or care in any way. Your doctor will then discuss with you any other treatments that are available.

If I do decide to join the drug trial, what happens if I change my mind later?

You can withdraw from the trial at any time without having to give a reason. You can then discuss different treatment options with your doctor. On the other hand, if you originally decided not to take part, and later change your mind, you can discuss this with your doctor.

Are there different types of trials?

Yes. There are many different ways in which trials are organized and several methods of analysing statistics or information. Organisations like Breast Cancer Care and Cancerbackup, among others, produce information about clinical trials.

How do I find out if there is a trial being run somewhere else which might benefit me?

First of all, ask your doctor who may know of research being carried out in a regional cancer centre or specialist hospital. Second, if you have heard about a trial in another hospital you can contact them directly. You will usually need a referral letter from your cancer specialist or family doctor in order to be seen by the doctors doing the trial. And

finally, you might be able to find out from one of the cancer information services, such as Cancer Research in United Kingdom.

In terms of a clinical trial, what does ‘eligible’ mean?

It means that you fall into a strictly-defined group of people needed for this particular trial. When the doctors design a clinical trial, they have to lay down clear guidelines about who is included. For example, a trial of a drug for post-menopausal women won’t give useful results if some of the women are much younger. If you don’t come within the guidelines you will not be able to take part in the trial. So you may not be eligible for a trial even if it’s of a new treatment for the same kind of breast cancer that you have.

Can’t I get the new treatment if I’m able to pay for it?

No, offering to pay will make no difference if a clinical trial is being used to test or evaluate a new treatment.

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