Clinical trials: questions to ask
Here are some questions you may like to ask if you are invited to take part in a clinical trial. Many of the trials taking place in cancer care involve new drugs, so this example is used throughout the questions.
In this section:
- What is known about the new treatment or procedure?
- How is the treatment given?
- What are the possible side effects if I take part in a trial?
- What other treatments are available if I don’t take part in this trial?
- Will I get better treatment if I agree to enter a trial?
- How is the trial treatment different?
- Will the treatment benefit me?
- Will I have any extra investigations or tests?
- Will I be asked to take part in more than one trial?
- Do I need to come to the hospital more often?
- Will my family doctor be informed?
- What if I am worried about an unusual reaction?
- What if new information becomes available?
- What happens when the research study stops?
- What if something goes wrong?
- Who is organising and funding the research?
- What happens to information gathered for the trial?
- Can I find out the results of the trial?
- Who can I contact if I have any concerns or problems?
What is known about the trial treatment offered to you will vary, depending on its stage of development. When drugs have been recently developed there may not be very much information available. If several other trials have been carried out already, a more detailed explanation should be possible.
The researcher will be able to tell you how treatment will be given. This is decided when a protocol is drawn up. If any changes need to be made later, they will be made clear to you.
What your doctor, or the researcher, will be able to tell you about side effects depends on how much research has been done already. Some clinical trials are conducted specifically to find out about possible side effects.
You should be told, as far as possible, what to expect. You must also report to the doctors or research nurses anything unusual which could be due to treatment.
When you are invited to take part in research looking at a treatment, you should always be told what other treatments are available, and the benefits and risks of these other treatments.
Often it’s difficult to say whether your treatment will be better as part of a trial, especially if the treatment being trialled is very new. Many trials are done to find out which is the better treatment by comparing the best known available with a new therapy.
During a trial, all participants are carefully monitored. Many studies have shown that patients on clinical trials often receive more attention than patients who don’t take part in trials.
Your doctor will be able to explain what other treatments are available and the exact differences between those and the trial treatment being offered to you. Sometimes the differences may be only slight but sometimes they may be quite marked. Occasionally, there may not be an alternative treatment, if a drug or therapy is very new or if you have exhausted all known treatment options.
Every person can respond differently to treatment. It often takes time to find a therapy which suits you best and controls your cancer. This is also true with trial treatments.
Your doctor may be able to tell you in general terms what percentage of people can be expected to benefit from new drugs. The doctor won’t offer you a treatment unless there is a potential benefit. If you don’t respond to treatment, your doctor will withdraw you from the trial and discuss your future care with you.
Your doctor may be able to find out how effective a new treatment is by using the same blood tests or scans that you would normally have. However, if the treatment is new, different side effects may occur and more tests may be needed. You should find out what these might involve.
With early phase trials you will also require additional block tests to monitor the levels of drugs in your body at specific times.
Your doctor may ask you to take part in another study which is running alongside a treatment trial, for example a new way of managing side effects.
It is also quite common to study how treatments affect you, your everyday life and daily activities. These quality-of-life studies may be part of the trial or may be a separate project. Researchers may ask you to fill in a questionnaire or take part in an interview. Your participation in these studies is also completely voluntary, and you should consider whether you are prepared to devote the extra time and effort involved.
Your doctor will inform you about the time commitments required of you if you decide to take part in a trial. This will vary from trial to trial and will often involve more visits than usual to the hospital. You should be told how often you will need to visit the hospital and how long the visits will be. Extra visits may cost you time and money; ask if there is money available to cover your fares.
Your doctor or researcher should be able to provide a plan for you but, as with all treatments, this may need to be adjusted as situations change. The plan should tell you what tests to expect. These may include blood tests, X-rays and interviews.
If the clinical trial is not at a hospital near you, ask if you can attend your local hospital for any of the trial treatment. For example, you may be able to have a blood test locally.
Your hospital doctor or researcher may contact your family doctor (GP) to tell him/her that you are taking part in a clinical trial. This depends on the type of trial and it may not always be necessary.
If specific details of your study need to be passed on, the doctor will ask your permission to do this. You will also be asked if you mind having your hospital doctor contact your GP about your participation. You will be given the opportunity to ask your GP for advice about taking part if you wish.
If you or your family doctor are worried about an unusual reaction, or one which you haven’t been made aware of, contact the research team straight away. Likewise, if a symptom you have been told to expect doesn’t occur, you may also be concerned. Again, please phone the research team.
Before leaving the ward or clinic you should have been given contact names and phone numbers of healthcare professionals who can answer your questions at all times. These details should also have been filled in on your patient information sheet.
Your doctor or researcher should inform you if any information about the treatment / drug being studied becomes available during the trial.
Your doctor will discuss with you whether you want to continue in the study. If you decide to withdraw, your doctor will make arrangements for your care to continue. If you decide to continue in the study, you may be asked to sign an updated consent form.
You may want to ask what treatment you will be given if you need further treatment when the trial finishes.
During any treatment you will be observed very closely to make sure that you’re not placed in danger. When you enter a clinical trial, the tests and checks on your health may need to be increased and you will be asked to report anything unusual. Any extra tests are to help safeguard you from possible effects associated with the new treatment. Minimising your risk of side effects and any harm is a major goal of all trials.
If you have a serious reaction to a new or standard treatment, treatment will be stopped. Your doctors, or other researchers, will do all they can to make sure you don’t suffer any lasting consequences.
You may want to ask who is funding the trial. The research may be funded by:
- An academic institution (such as the Institute of Cancer Research or a hospital department)
- A charity (such as Cancer Research UK)
- A pharmaceutical (drug) company
Sometimes, sponsors of a study will pay a hospital department or research fund for the patients included in a study. The doctor conducting the research may be paid for looking after patients in the study.
All the records kept about you during the trial are kept confidential. However, data may be sent to the company or organisation sponsoring the study. Your records may also be inspected by national or international bodies who oversee medical trials to make sure the trial is being carried out correctly.
Any information which goes outside the hospital will be coded so it won’t be possible to identify you as an individual. You also won’t be named in any articles when the trial results are published.
Yes – ask your researcher about the progress of the results. Some trials are completed in weeks or months and these results are available quite quickly. Other trials are carried out over several years and it may be a long time before the final results are known, but you may be able to find out how the trial is progressing.
You should be given the names and contact details of the healthcare professionals to contact if you have any questions or concerns while you are taking part in the trial.