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1. What are clinical trials?
2. Benefits and drawbacks of taking part in a clinical trial
3. How are clinical trials approved?
4. Phases of clinical trials
5. Can I take part in a clinical trial?
6. Where can I find out more about clinical trials?
7. Further support
Clinical trials are research studies involving people. They aim to improve diagnosis, treatment, side effects and quality of life.
For people with breast cancer, clinical trials might include:
Benefits of taking part in a clinical trial might include:
Drawbacks of taking part in a clinical trial might include:
New cancer drugs or treatments are tested and researched thoroughly before they are used in people.
Before a clinical trial begins it has to be approved by a group of independent scientists and then by a research ethics committee. The committee make sure the trial is safe and in the best interest of patients. They are made up of healthcare professionals as well as people without a medical background.
There are other safeguards in place for people taking part in trials. For example:
If during a trial it becomes clear that one treatment is much better or worse than the other, or a treatment is causing severe side effects, the trial will be stopped and eligible patients will be offered the most effective treatment.
Clinical trials testing new treatments are divided into different phases. Phases 0 to 2 usually look at whether a drug is safe and any side effects it causes. Phases 3 and 4 aim to test whether a new treatment is better than existing treatments.
Phase 4 trials are carried out after a drug has been licensed. They look at drugs which are already available for doctors to prescribe rather than new drugs that are being developed.
You may be asked to join a phase 0 trial, although most trials involving cancer patients start at phase 1.
Find out more about the different phases of clinical trials on the Cancer Research UK website.
Your specialist may offer you the opportunity to take part in a clinical trial if you’re eligible. Or you could ask them about a trial you would like to take part in, or if there are any others that may be suitable for you.
If you’re interested in taking part in a trial, talk it through with your specialist. They’ll be aware of the main breast cancer trials that are in progress and which ones are happening in your area. They can advise you according to your situation.
Every clinical trial has strict guidelines about who can be involved. For example, you might need to have a certain level of fitness to take part.
If you’re not able to take part in a particular trial, you may be disappointed. However, your treatment team will continue to support you and offer the best treatment and care available.
Deciding whether to take part in a clinical trial can be difficult and sometimes feel overwhelming.
If you’ve been asked to take part in a trial, your specialist or a research nurse will discuss exactly what’s involved with you. You should be given written information with all the details of the trial. This should include information about the type of trial, the possible benefits and risks, and whether extra tests or hospital appointments are needed. All information about participants is kept confidential.
You should be given time to make a decision about whether to take part.
It is important you understand what is involved before you give consent to take part. Ask your specialist or the research nurse any questions you may have. If you don’t feel that taking part in a trial is the right option for you, you can decline without giving a reason.
You might like to ask some of the following questions if they’re not already covered in the information given to you by the trial team.
Some people find it useful to write a list of questions they want to ask and take it to their appointment. You can print off our list of suggested questions below to take with you.
Once the details of the trial have been explained, you should be given written information and time to think it over and make your decision.
If you decide to take part in a clinical trial, you will be asked to sign a form saying that you agree to take part and understand what is involved. This is called giving informed consent. However, this does not commit you in any way and you can withdraw from the trial at any time if you change your mind.
If you’re thinking of leaving a trial you can do so at any time and you do not have to give a reason. Stopping taking part will not affect any future care you receive. If you want to leave a trial you can discuss this with your specialist or research nurse.
You cannot be entered into a clinical trial without your knowledge and without giving your consent.
You will have blood and tissue samples taken during your diagnosis and treatment. For example you may have tissue removed during a biopsy.
Your specialist may ask for your consent to use your samples for research. These samples can be looked at to:
You’ll find research projects and clinical trial opportunities on our Forum.
You could also ask a member of your treatment team if they know about any clinical trials that you might be able to take part in.
Deciding whether to take part in a clinical trial can be overwhelming and you may feel unsure about the right option for you.
Speak to people who have been through similar experiences on our confidential Forum. Breast Cancer Now’s Someone Like Me service can put you in touch with someone who has had a similar experience, so you can talk through your worries and share experiences over the phone or by email.
You can listen to other people’s experiences of clinical trials on the Healthtalk website.
If you would like any further information and support about clinical trials for breast cancer or just want to talk things through, you can speak to one of our experts by calling our free Helpline on 0808 800 6000.