If you are considering taking part in a clinical trial, you should be given plenty of time to ask questions. Write your questions down before seeing your consultant or nurse. You might find it helpful to take someone with you to appointments to help remember what you are told. You should feel free to ask about anything that is on your mind. There is no such thing as a silly question.
It might help to ask some of these questions:
- How will this trial help people?
- What will the trial involve?
- How can it benefit me? Will it benefit me?
- What treatment will I have if I don’t take part in the trial?
- What is known about the trial treatment?
- What are the possible side effects of the trial treatment?
- What are the possible risks?
- How do you know the trial is safe?
- Does the trial use placebos?
- Will I be able to choose the treatment if I am in the trial?
- Will my doctor be able to choose the treatment I have in the trial?
- Will I know what treatment I am having if I take part in the trial?
- Will the trial take longer than standard treatment?
- Where will I have treatment?
- Will I have to stay in hospital?
- How often will I have treatment?
- Will I have more tests than I would in routine care? If so, what are the risks associated with having these extra tests?
- Will I have to fill in questionnaires about how I am feeling? If so, how many? How often?
- How will the trial affect my day-to-day life?
- Is there anything I can or can’t do while I am taking part in the trial?
- Can I take my usual medications?
- How many extra hospital visits will be involved?
- Will I be reimbursed for extra travel costs?
- Who will be in charge of my care?
- How long will the follow-up period be?
- What will happen if my lymphoma gets worse while I am in the trial?
- What will happen if I change my mind?
- What treatment can I have if I withdraw from the trial?
- If I benefit from the treatment, can I carry on with it after the trial ends?
- When will the trial results be published?
- How can I find out the trial results?
Taking part in a clinical trial isn’t a decision to be taken lightly. You might want to ask yourself some of the following questions to help you decide whether or not you’d like to take part in a trial:
- Do I understand what is involved in taking part in the trial?
- Do I understand the risks?
- Do I understand that I may not benefit from the trial?
- Have I had an opportunity to ask questions?
- Have my questions been answered well enough?
- Do I feel comfortable with the people who will be treating me? Do I feel I will be able to ask them questions?
- If the trial is randomised, am I happy that my doctor and I cannot decide which treatment I have?
- If the trial is blinded, am I comfortable that I will not know what treatment I am receiving?
- Am I aware of the implications for further treatment if I decide to withdraw?
- Are there any practical implications to take into account, such as travel and an increased number of visits to hospital? How will I manage them?
No – if you have lymphoma you won’t usually be paid for taking part in a clinical trial. However, in some trials you can be reimbursed for travel expenses and refreshments. Ask your trial team about this. You don’t have to pay to take part in a clinical trial.
No – there are trials for people in different situations. Clinical trials can offer access to experimental treatments for people who have already had the standard treatments and need more treatment. However, they are also carried out for other reasons. Clinical trials might aim to improve standard treatment for people having their first treatments. They might be testing if a change to standard treatment can reduce side effects or improve outcomes. Some trials and studies don’t involve treatment at all – they might give researchers access to your samples and information about your response to treatment so they can learn more about lymphoma.
Your doctor might ask you if you are interested in taking part in a clinical trial, or you can ask your doctor if there is a clinical trial suitable for you. You can also search for trials yourself. There are several places you can find information about trials that might be suitable for you.
Some of the information you find might be very technical. If you find a trial that you might be eligible for, discuss it with your doctor. They can check the eligibility criteria and find out whether you may be suitable.
You might find out about a trial that is not running at your hospital. Discuss this with your medical team. You might wish to ask your doctor about being referred elsewhere if treatment at a different hospital is something you would consider. If you are referred to another hospital, your doctor will need to share information with staff members there. Think about the practical implications of being treated at another hospital, particularly travel and accommodation costs.
Only a small proportion of people with lymphoma are treated as part of a trial. There are lots of reasons for this. There are only a small number of trials running at any one time. Trials have strict eligibility criteria to make sure participants are safe and that the results of different treatment groups can be compared fairly. You might need to travel to another centre to take part in a trial. There is not a suitable trial for everyone at any one time. Sometimes a new trial might open so if there is not a trial that is suitable for you initially, you may find one at a later date.
Your doctor can talk to you about your options if there isn’t a trial you can take part in.
A trial team will look after your care during the trial. The study investigator is usually a consultant at your hospital and will oversee your care as part of the trial. You will also have access to experienced research nurses or a clinical nurse specialist with a research interest. These nurses are dedicated to the support of patients involved in the clinical trial. They can discuss any worries or questions you might have.
In this video, the team from University College London Hospital (UCLH) talk about the staff who might look after you if you take part in a clinical trial.
Treatment trials are carried out in phases. The phase of a trial reflects how much is known about a particular treatment. More is learnt about a treatment as it goes through the different phases. In early phase trials (phase 1 and 2), less is known about the treatment than in later phase trials (phase 3 and 4).
You can’t usually choose your treatment. The treatment is set out in the trial protocol so you are given information about the different treatments before you enter the trial. In most cases you are told what treatment you are having. Occasionally a trial is ‘blinded’, which means you won’t know what treatment you are having.
A placebo is a dummy treatment – it doesn’t have any active medication in it. It is used to make sure that the results of a trial aren’t affected by whether or not participants know they are having active treatment.
If you need treatment for lymphoma, you will not have placebo treatment on its own. You might have a placebo in addition to active treatment. You won’t know if you are having the placebo or another active treatment.
Measurable disease means your lymphoma can be detected by the tests or scans used in the clinical trial. This means the trial can measure any changes in your lymphoma. The exact definition of ‘measurable disease’ varies from trial to trial depending on the type of lymphoma being studied and the tests used.
Most people who need treatment for lymphoma have measurable disease.
You should be given contact details for people you can speak to if you are unhappy about your care during the trial. If you don’t have these contact details, ask for them.
Personal and medical information about you will remain confidential. The sponsor of the trial (for example a pharmaceutical company) and the authorities that regulate the trial can look at your notes but they are also bound by confidentiality agreements. Information about you that is collected and recorded as part of the trial will have a code number attached to it instead of your name. Your information won’t be taken from your hospital without being made anonymous.
Clinical trials must have insurance to cover the people taking part against anything going wrong. Ask your study team for more information about this. If you have or need to take out any personal insurance, for example travel insurance, life insurance, income protection or health insurance, you will usually need to tell the insurance company that you are being treated as part of a clinical trial. It could affect what the insurance company will cover.
Tissue samples from your biopsy and blood samples are often stored for use as part of a trial or as part of a biobank (collection of cancer samples) for future research. This does not happen without your knowledge. In some trials, you can opt out of having your samples stored. Some trials only require samples for research and do not involve treatment.