Every new treatment for people with lymphoma needs to be tested in a scientific way. This is done in clinical trials – medical research studies involving human participants. Clinical trials for lymphoma study several aspects of this type of cancer. Many are treatment trials, which can test:
- A new treatment – if it works; if it is safe; whether it is better than the current standard treatment; if it can work in combination with other treatments; how it works and how your body processes it.
- Existing treatments – comparing one treatment with another; comparing different ways of using treatments we already use (for example a different dose or schedule); or testing if treatments used in other diseases could help people with lymphoma.
For a drug to be widely used in the UK, it must be licensed by the Medicines & Healthcare products Regulatory Agency (MHRA), which licenses drugs only in the UK, or by the European Medicines Agency (EMA), which licenses drugs across Europe. A drug can only be licensed after many checks have been carried out and the benefits of the drug are believed to outweigh its risks. The results of treatment trials are needed for a drug to be licensed.
Trials that don’t involve treatment can explore screening tests or methods; the best ways to diagnose lymphoma; what causes lymphoma (the molecular biology of the disease) and how that knowledge can be used to design or choose treatments; the best ways to monitor response or follow-up people after treatment and prevention strategies.
If you are considering entering a trial that does not involve treatment, talk to your medical team about exactly what is involved. There is more information on these types of trials in our clinical trials booklet.
Trials are organised to answer questions in a scientifically valid way. They are also designed to be fair and safe for the people who take part.
- phase 1 are small trials that often aim to find the best dose of a drug or to test its safety
- phase 2 trials aim to find out more about the safety and effectiveness of the treatment
- phase 3 are larger trials that often test a new treatment or new way of using a treatment against the standard treatment
- phase 4 trials are done after a drug has been licensed, normally to find out more about it.
Clinical trials of new treatments are planned based on the results of laboratory and animal studies to make sure the trial is as safe as possible for the people taking part.
Other types of trials are not done in phases as this is not necessary. For example, where only established tests are done, samples are taken or questionnaires are given.
When trials compare one treatment or one way of using a treatment against another, they are often randomised. A computer randomly assigns the people taking part to different treatment groups. There are often two groups or treatment ‘arms’ but there can be more.
If you are in a randomised trial, you can’t choose which treatment you have and neither can your doctor. Randomisation is used to make sure that people in each treatment group have similar characteristics. This means the results from each group can be compared in a scientifically valid way.
Read Michael’s personal experience of a randomised trial.
In some trials, you do not know which treatment you are having. This is called a ‘blind’ trial. Often, your doctor doesn’t know either, and the trial is called ‘double-blind’. Blinding is used because knowing what treatment you are on could influence your or your doctor’s expectations about it. This could affect the results of the trial as people can’t help being influenced by knowing what the treatment is. The trial organisers keep a record of who is having which treatment so they can tell your doctor should any problems occur.
One group may have a new treatment added to a standard treatment. The other group might have a placebo (dummy treatment) instead of the new treatment.
Remember that the trial is designed to find out which treatment is best. The organisers do not know that the new treatment is better than the standard treatment before the trial has been completed. The standard treatment might be just as good as, or even better than, the new treatment.
Setting up any trial takes a long time. Clinical trials in the UK are governed by strict laws. These laws protect the people taking part and help to ensure that trials are as safe as possible.
Organising a trial usually involves the following process:
- Making a proposal – clinical trials are set up by individuals or organisations who design a trial to answer a question. A trial may be organised by a university or a pharmaceutical (drug) company.
- Getting funding – trials are very expensive. Funding has to cover research staff, administration, drugs and tests, hospital stays, analysis of the results and the costs of following-up participants, sometimes long after treatment has finished. Cancer trials in the UK are usually funded by a pharmaceutical company, a national charity or a governmental organisation. Funding often comes from a combination of sources.
- Developing a protocol – every trial needs a document that describes the study in detail. The doctors and nurses treating you have to follow the procedures described in the protocol to make sure everyone who participates in the trial is treated in the same way. The protocol includes information on why the research is needed; who is eligible and how many people are needed for the trial; the treatments, tests and/or methods involved; how participants will be monitored and for how long; how long participants are expected to be involved in the trial and when the trial will end.
- Getting the go-ahead – all trials must be approved by an independent ethics committee and by the MHRA, a governmental organisation that regulates the use of medicines in the UK. These agencies look at the protocol carefully to make sure the researchers are working in the participants’ best interests.
Once the protocol has been approved and funding has been secured, investigators can begin to recruit people for the trial. If a trial is running at your centre and your doctor thinks you could be suitable, he or she might invite you to take part. You can choose not to get involved. Your decision won’t affect the care or treatment your doctor gives you.
If you do consider taking part in a trial, you might want to read some of the advantages and disadvantages of taking part. Take time to carefully read all the information you get. Ask your doctor questions to make sure you understand what is involved. You can show the information to someone else, like a family member or your GP, should you want to.
Most treatment trials follow a similar process:
- Informed consent given – you are given an Information Sheet to read. Your doctor explains the trial and you have the opportunity to ask as many questions as you need to. You can show the information to someone you trust like a family member or your GP if you want to. If you decide to take part, you are asked to sign an Informed Consent Form to show that you understand the information you have been given and agree to take part. You usually have to wait at least 24 hours between being given the Information Sheet and signing the Informed Consent Form. This is so the researchers can be sure you have had time to think about it.
- Eligibility assessed – once you agree to take part, you need to have tests to check if you are suitable for the study. You can only take part if you meet all eligibility criteria.
- Treatment allocated – if you are eligible for the study, you are usually assigned to a treatment group. This might be randomised, which means your doctor can’t choose your treatment. In some studies, you are not told what treatment you are having – a ‘blinded’ study.
- Treatment – during the treatment period, you visit the hospital regularly for treatment and tests. You might be given some treatment to take at home. Information on tests and treatments is provided in the Information Sheet. This includes the schedule, methods and how long you are treated for.
- Follow-up – when treatment is finished, you attend the hospital regularly for check-ups to see how you are doing.
Trials are monitored closely throughout to make sure any problems are picked up and solved quickly. The protocol can be changed if necessary during the course of the trial. A trial may be stopped early if there are concerns about safety or if it is never likely to come up with a result. This can happen if the organisers have difficulty recruiting enough people to take part. If it becomes obvious one group is doing much better than the other groups, the trial might close early and everyone might switch to the better treatment if possible.
In order to join a clinical trial, you must meet its eligibility criteria. These criteria allow the researchers to compare like with like. If the people in the study are in a similar condition to start with, any changes detected between groups during the study are most likely because of the treatment, not some other factor. Eligibility criteria are also important in making the study as safe as possible for the people taking part. They include:
- inclusion criteria, which set out who can join the trial. For example, the exact type of lymphoma participants must have, the stage of their lymphoma and whether they have already had treatment or not. The criteria usually give an age range for participants.
- exclusion criteria, which set out who can’t join the trial. For example, certain previous treatments might interact with the study drugs so you can’t join the trial if you’ve had them. Other criteria relate to safety – if you have other medical conditions you might not be able to join. Pregnant and breastfeeding women are normally excluded from clinical trials to prevent harm to the baby.
Your doctor might ask you if you are interested in taking part in a clinical trial. You can ask your doctor if there is a clinical trial suitable for you. You might be able to be referred to another hospital if there is not a trial running at your hospital. Your medical team are used to requests like this and won’t be offended if you ask about a trial at another hospital.
You can find information about trials that might be suitable for you in our regularly updated database of clinical trials and research studies open for people with lymphoma in the UK.
There are other sources of information that help people find out about clinical trials, including:
- National Institute for Health Research (NIHR) – a government organisation that aims to improve the health and wealth of the nation through research. It has a searchable database of clinical trials – the UK Clinical Trials Gateway.
- Cancer Research UK – a charity that provides information and statistics on all types of cancer. They fund research and maintain a database of clinical trials taking place in the UK.
If you find out about a trial that you might be eligible for, discuss it with your doctor. You can print the information you find and show it to them. They are best qualified to give you advice about other hospitals. They can also check the eligibility criteria and find out whether you may be suitable.
Don’t be disappointed if there isn’t a trial that is suitable for you. There are relatively few trials running at any one time and they are only open to new participants for a limited period of time. Even if you have the right type of lymphoma, you might not be eligible to take part. You will still be treated with the best available treatment.
Before you join a clinical trial, you are given an Information Sheet that describes what happens during the trial, and the possible risks and benefits of taking part. Your doctor discusses the Information Sheet with you and you can ask them as many questions as you need to. If it is a treatment trial, remember there is no way of knowing how the treatment will affect you.
The trial team is not allowed to try to persuade you to take part in a clinical trial. They have to give you all the information they have and tell you all the possible disadvantages of participating in the trial. It might feel as though they are trying to talk you out of participating, but you do need to know what the trial could mean for you.
Read Sue’s personal experience, where she describes some of the advantages and disadvantages of taking part in a clinical trial.
Advantages of taking part in a clinical trial
Most of the advantages of taking part in a clinical trial are part of good medical care. These include access to expert staff, good quality information and careful follow-up. You should have these as part of regular care. Clinical trials can also provide you with:
- Access to expert support and advice about the trial procedures and treatments – doctors and nurses following the trial protocol act on the most current information about someone in your situation. You also have access to experienced research nurses or a clinical nurse specialist with an interest in research. They can explain the trial to you and help you discuss any worries with your medical team.
- Close monitoring – clinical trials pay particular attention to side effects (unwanted effects of a medical treatment) and to your response to treatment. You may have more tests than usual to see how you are getting on.
- Longer follow-up – you might be followed up for longer than usual. The study team usually wants to know what happens with your health long-term.
- Access to the latest treatments – many clinical trials provide you with an opportunity to have an experimental treatment, which might work better than the current standard treatment. Clinical trials can also offer access to another treatment when all standard options have been tried.
- Access to information – for a trial to be approved, participants have to be given good quality information about their situation, the treatment involved and the possible risks and benefits of the trial. You are likely to receive more written information than you would in standard practice. The study team are available to answer your questions.
- Helping others – clinical trials can result in important changes in the treatment of lymphoma. Thanks to past participants in clinical trials, treatment is now safer and more effective than it used to be. Taking part in a clinical trial means you help other people diagnosed with lymphoma in the future, even if the trial doesn’t benefit you directly.
Read Carol’s personal experience of several clinical trials of new treatments.
Disadvantages of taking part in a clinical trial
Your research nurse can help you discuss your concerns and assist you in deciding whether a clinical trial is suitable for you.
Some of the factors you should consider include:
- Uncertainty about the outcome – clinical trials are set up to answer questions. No one knows for sure what will happen. You might be in the group with a worse outcome overall or you might get unexpected side effects. There is more uncertainty in early phase trials, eg phase 1, where less is known about the treatment’s effects than in later stage trials. Phase 1 trials usually give access to a treatment only for people with no other options.
- No choice of treatment – you might not know what treatment you are having if the trial is a blinded trial. Sometimes your doctor won’t know either. There are some things to remember though:
- You might be disappointed if you are in the control group. However, the control group is given the best standard treatment and it might be just as good as or even better than the new treatment.
- If it becomes obvious one group is doing much better than the other, the trial might close early and everyone might switch to the better treatment if possible.
- Extra hospital visits and tests – these can be reassuring but could be stressful or inconvenient for you. Discuss the risks of any extra tests with your medical team, eg extra scans can increase your exposure to radiation. These risks are assessed when the trial is designed, but it is important that you are comfortable with them.
- Worry about the information you are given – taking part in a trial means dealing with a lot of information. Talk to your medical team if anything is troubling you or you find the information difficult to understand.
Remember, you don’t have to enter a clinical trial even if your doctor asks you if you would like to. It does not affect your standard of care if you say no.
You might find our lists of questions to ask yourself, questions to ask your medical team and frequently asked questions useful. If you’d like to know how other people have felt about being in a clinical trial, read our personal experiences section.
Consider the information you are given and ask all the questions you want to. If you decide to take part after this, you need to sign a consent form. Signing the form gives your informed consent. This means that you understand what is involved in the trial and agree to take part.
You can change your mind at any time and withdraw from the trial without giving a reason. Signing the consent form doesn’t mean you have to continue to take part if you don’t want to.
If you do decide to withdraw from the trial, you might not be able to continue to have the same treatment. You’ll usually be given the standard treatment for someone in your situation. Sometimes, the treatment you have in the trial influences what treatment you can have next, for example it might not be possible to switch from one chemotherapy regimen (combination of drugs) to another. Ask your trial team what may happen if you change your mind before you agree to take part.
After you finish treatment as part of a trial, there is usually a long period of follow-up, often several years. The trial team is interested in long-term as well as the early effects of a treatment. As part of follow-up, you attend the hospital regularly for tests and a check-up. Details of what is involved are included on your Information Sheet.
The Information Sheet should also include information on what the researchers are measuring to see how well a treatment works, eg response rate – whether your lymphoma shrinks because of the treatment.
It can take several years before the results of a clinical trial are available. This is because it takes time to recruit enough people, treat them according to the trial protocol, and follow them up afterwards. Researchers also need to analyse the results before they can say what the outcome of the study is. Results are usually reported at major medical conferences and in medical or scientific journals.
Clinical trials are the only way that treatments for lymphoma can be improved in the future. You can ask your medical team if you are interested in taking part in a clinical trial. They can help you find out if there is a trial suitable for you and give you the information you need to decide if it is right for you. You do not have to take part in a clinical trial if you don’t want to. It is your decision. Turning down an offer to take part in a clinical trial does not influence the standard of care you receive.