Take part in a trial
A clinical trial is a research study that uses people to find new ways to improve health. They are vital to the development of NHS care and to ensuring that the next generation of patients receives the best, most effective and most advanced treatment and care possible. This new knowledge relies on current patients and members of the public to volunteer to take part.
Clinical trials can:
- test new treatments to see if they help with certain diseases or conditions better than the current treatments
- test treatments or lifestyle changes to see if they prevent or lower the chance of getting certain diseases
- test new ways of finding out if people have certain diseases
Clinical trials that test new treatments, such as medicines, fall into one of three types. The type of trial depends on its goal and how much testing the treatment has already had.
The different types of treatment trials are:
- phase 1 (I) trials – in Phase 1 trials, researchers check the safety of a new treatment. They learn how the medicine should be given, how often it should be given, what dose is safe, and what the side effects are.
- phase 2 (II) trials – in Phase 2 trials, researchers give a new treatment to a group of people with a certain disease. They check the treatment's side effects and how well it works to treat the disease.
- phase 3 (III) trials – in Phase 3 trials, researchers compare a new treatment with the current treatment for a certain disease. They learn if the new treatment helps the disease better, worse, or the same as the current treatment. They also learn if the new treatment has more or fewer side effects than the current treatment.
Who can take part in a clinical trial?
It depends on the trial. Some trials (usually Phase 2 or 3 trials) use only people with certain diseases or conditions, or whose family members have certain diseases or conditions. Other trials can use people who are healthy.
Not everyone who wants to be in a trial can be in one. To be in a trial, you need to meet certain conditions. Often, you need to have the disease or problem being studied. Other conditions usually have to do with the health of your heart, liver, kidneys, or other organs. To see if you meet the conditions needed for the research, you might need to answer questions or undergo a medical examination or tests like blood tests.
If you are a patient at NUH, you will usually be asked by the doctors or nurses treating you if you would be willing to take part in current research happening in our hospitals. You are free to say yes or no, and your treatment and care will not be affected by what you decide.
What are the benefits of taking part in a clinical trial?
People can benefit from taking part in clinical research trials in different ways:
- Help to advance scientific and clinical knowledge about our health and wellbeing
- the chance to test a new treatment at an early stage
- work with research experts who have a great deal of knowledge of the disease and have your progress regularly monitored
- help people who will have your disease in the future, by supporting the development of new and more effective treatments, therapies or medicines
- learn about your health and about clinical research in general
Before deciding whether taking part in a clinical research trial is right for you, you should consider all of the information available to you from the research teams. They will explain how the trial will work, any risks or side-effects that you may experience and also the benefits of the treatments being tested. They will also explain any downsides to taking part, for example that the new treatment they are testing could be less effective than the treatment you are already receiving.
Please be aware that:
- You might not get the new treatment – our research will compare a new treatment with the "usual" treatment for a disease. Other studies compare a new treatment with a "placebo". A placebo is a treatment that looks the same as medicine and is given the same way, but doesn't have any medicine in it. A placebo is used only if doctors aren't sure that the usual treatment helps or if there isn't any good treatment for that disease or condition.
- In studies that compare two treatments, half of the people get the new treatment, and the other half get the usual treatment or placebo. Neither you nor your researchers can choose which treatment you get. Also, in many cases, you won't know which treatment you got until the trial is over.
If you decide to take part in a trial, you will need to give your written consent.
Make sure you're happy with the trial and have been given all the information you want before you give your consent (permission). This may mean taking some time to think about it and talk it over with family or friends, unless a decision is needed urgently because of your medical condition.
If you decide to take part, you'll be asked to sign a form to say you're agreeing to take part in a trial and have understood what it involves. This is called giving your informed consent.
For people under the age of 18, a parent or guardian has to give informed consent.
Our experts check all trials – before and during them – to make sure that they are safe. Our research is also accredited by the relevant national regulatory or sponsoring organisation to ensure that we consistently meet all of the standards required to carry out clinical research in the UK. If there are signs that the treatment in a trial could be unsafe, the research team or the regulators will stop the trial.
During the trial, you will need to follow all of the instructions about visits, tests, and treatments. This may be over a period of days, weeks or months. If you experience any problems, issues or side-effects, you should contact your research doctor or nurse.
You may decide to stop taking part in a trial if your condition is getting worse or if you feel the treatment isn't helping you. You can also choose to leave at any point without giving a reason and without it affecting the care you receive.