What are clinical trials?
A clinical trial compares the effects of one treatment with another. It may involve patients with a particular disease or condition, healthy people, or both. Trials are designed differently depending on what is being researched.
Very often, the clinical trial takes place as part of the treatment and care that you receive at your GP surgery, at hospital or in other NHS services.
Your doctor, nurse or clinical team will tell you about research that you may be eligible to join. You can also ask them about research that is taking place that you may be able to take part in.
You will find more information about taking part in the sections below.
Clinical research is finding out what works best in patient care in specific areas through a ‘study’ or ‘trial’. The aim is to answer a question, using a carefully designed method.
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 called 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. 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.
You will usually be asked by the doctors, nurses or healthcare professional treating you if you would be willing to take part in a trial. 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.
Using your data in our research
Using your data
Protecting your information
Our research is only possible because of the patients, families and carers who agree to use their data as part of our research. At every stage of our research, we are committed to protecting your privacy, confidentiality and dignity. That includes using your data responsibly.
Our researchers are specially trained, qualified and authorised to work with your data. We handle and store data in the most secure ways possible. We will only use your data with the proper approvals, following independent review of how we plan to use the data for research and with full security of your data in place. We will only use your data to improve health and care.
The video above summarises how the NHS uses data to save lives and improve treatment and care; we are grateful to the Understanding Patient Data initiative for these resources. You will find more information and resources on the Understanding Patient Data website.
Our commitment to you
At NUH we make the following commitments about the data we keep about you and the way that we protect it. We will:
- Keep the right information to provide services and fulfil our legal responsibilities to you
- Keep your records safe, secure and accurate
- Only keep your information as long as necessary
- Collect, store and use the information you provide to the data protection standards and the laws that govern data protection
Sharing data for research
By bringing together small amounts of data from many thousands of patients, health researchers and scientists can look for patterns across the population. This type of data analysis can be used to help:
- understand more about disease risks and causes
- improve diagnosis
- develop new treatments and prevent disease
- plan NHS services
- improve patient safety
How the NHS uses data for research in the UK
The Health Research Authority (HRA) is the national body which protects and promotes the interests of patients and the public in health and social care research. It provides information about how data is used for research in the UK. You can find details of this information on the HRA website.
Choose how your data is used
You can choose if your health data is used for clinical research or for NHS and social care planning. Find out about how health data is used nationally and about your choices on the NHS website.
Data Opt Out
You can choose how your data is used by the NHS for planning and clinical research.
Find out more about the Data Opt Out on the NHS Digital website.
We are working with our partners in the University of Nottingham to develop the skills and capabilities to analyse extremely large amounts of data for research.
We are also working nationally as part of information collaborations and new developments in research data to improve healthcare across the country.
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.