What are clinical trials?
Clinical trials cover a wide range of different types of research. Trials are often used to test new medicines or vaccines, but they can also be used to look at new combinations of existing medicines.
Trials can also be used to test whether giving a treatment in a different way will make it more effective or reduce any side effects. Some trials are designed to try out new ways to prevent a particular disease in people who have never had the disease, or to prevent a disease from returning.
Clinical trials are not always about testing medicines, they can be used to find ways to help people change their behaviour or lifestyle. This could include an education programme designed to improve a person’s understanding of their medical condition so they can manage it more effectively, or psychological treatment such as cognitive behaviour therapy to treat anxiety or depression.
Why participate in research?
People who take part in research often feel that they are taking an active part in their health care. They are also assisting others, by helping to find the causes of problems and the best treatments for these.
Is it safe to participate in research?
All research, particularly clinical trials are carefully designed to reduce any risks and get the most benefits for everyone taking part, whatever treatment they receive. Some research will have very little risk involved. However, the risks of a trial of a new treatment may be greater when less is known about the treatment being tested. Before any drugs are first given to people, they will have been developed in a laboratory and tested for safety.
On occasion, the treatment may cause side effects that doctors cannot predict. Sometimes these may be unpleasant and, extremely rarely, can be serious. You should be told everything the researchers know about any possible risks and side effects, and why the trial is necessary, so that you can make an informed choice about whether to take part.
If you take part in a clinical trial you will be monitored regularly during and after the study. You will have regular tests and you may be asked some extra questions about how you are feeling. The research team will always be available to contact during this period.
What is informed consent?
A doctor, nurse or other researcher should get your permission (your ‘informed consent’) before entering you into a research study. They cannot enter you if you do not give your informed consent.
However, there are a few exceptional circumstances when people might be entered into a study without their informed consent (for example, in a trial of the treatment of head injuries or dementia, when the individual may not be able to give consent). In these cases the permission may be given by a relative or other legal representative.
If a study involves children, the process of getting informed consent is different and will be fully explained to you by our researchers.
It is important that you are satisfied that you have enough information to make an informed decision and to give your informed consent.
Can I quit the study after I agree to join or once it has started?
You can leave a study at any time without giving a reason, even if you have already given your consent to be part of it. If you are part way through a study the researchers may want to see you one last time to give you a medical exam just for your safety.
Will I get paid to participate?
Some studies provide compensation for time and travel. Each study is different and the compensation offered will be included in the project information and discussed with you.
Where can I find out more?
You can find out more about clinical trials by downloading and reading the flyer 'Clinical Trials: What they are and what they’re not' from the National Institute of Health Research. They explain in more detail what clinical trials are, why and how they are carried out and the types of questions you should ask before you agree to be part of the trial.