Clinical Trials Information Hub
How clinical trials are run safely
Find out how patients are kept safe and how clinical trials are checked and monitored.
How clinical trials are funded
Clinical trials in the UK are mainly funded by the government, drug companies and charities.
All trials, no matter who funds them, are checked and monitored in similar ways to make sure that everyone involved is protected. Each trial also has a sponsor who is responsible for running the trial. The sponsor may be the organisation funding the trial or the institution hosting the research (for example, a university or a hospital).
How clinical trials are planned
Once a group of researchers have an idea, they need to develop a protocol.
A protocol is a detailed plan for the trial, which includes:
- why the trial should be done
- the number of people involved
- who should be able to take part in the trial (this is called the eligibility criteria)
- details of the treatments given in the trial
- what medical tests people will have and when
Everyone involved in the trial must use the protocol. This keeps the people taking part safe and makes sure that the results of the trial are reliable.
How patients are kept safe
Every new treatment carries some risks, but the overall aim of a trial and the researchers is to reduce these risks for you. If at any stage the risks of the trial are greater than the benefits for you, the trial will be stopped. To keep you safe, all trials are monitored by the following groups.
The MHRA is a group of the Department of Health that makes sure the safety and quality of the treatment tested in a trial meets good practice standards.
Research Ethics Committees are groups run by the NHS Health Research Authority. They are independent groups of people including doctors, nurses, other medical staff, members of the public and sometimes lawyers. The group makes sure that your wellbeing and rights are protected. They also make sure that the information you are given tells you everything you need to know and is easy to understand.
These are national and local groups in your hospital or research centre that make sure that the trial is planned well and carried out safely. They also check that the trial is based on scientific knowledge and follows national guidelines and safe practices.
Consent is when you give your permission to have any medical treatment, test or examination.
Before giving your consent, you’ll be given a patient information sheet, which includes detailed information about the trial to help you decide whether you want to take part. You can also keep this to refer to during the trial.
Understanding the complex information to enrol can be overwhelming but our Clinical Trials Support Service is here to help you navigate through the entire process - whether you're a patient, carer or healthcare professional.
Once you’ve decided to take part in a clinical trial, you’ll have to give your informed consent and sign some forms.
These forms are important legal documents that protect both yourself and the organisation running the trial.
Before you give your consent, your trials team will discuss the trial in detail with you, the tests you may need, the frequency of your hospital visits and any known benefits, risks and side effects of the treatment. They will also discuss alternative treatments and options with you so you know about all of the options before making a decision. It’s important that you ask any questions that you might have.
Who will have access to my medical records?
The NHS and the sponsor (the organisation running the study) have strict confidentiality rules about who can and can’t view your information. Only the clinical and research teams who need to access your records will do so. Once you’ve agreed to take part in a trial, you’ll be assigned a trial number to make sure your information is kept anonymous. If your information needs to be sent out of the hospital the trial team will use this number only and all of your personal details will stay in your notes.
Contact our Clinical Trials Support Service
If you'd like tailored information and support to help you navigate through the clinical trials process, speak to our experts.
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Clinical Trials Information Hub