Find out more about Clinical Trials in our Patient and Information Leaflet here
- What are Clinical Trials?
Clinical Trials are medical research studies that test the safety and efficacy of treatments. They look at new ways to prevent, detect, or treat disease. Treatments can be new drugs, a new combination of drugs or new ways to use current treatments. A ‘trial’ when it comes to medical research is therefore a way of testing something.
Some trials involve healthy volunteers whilst others involve patients who might be offered the option of taking part in a trial during their care and treatment.
- Why are clinical trials important?
Before a drug can be prescribed we need to know if it works, if it works better than current treatments and whether it has any side effects. Until a well-designed trial has been completed, we may not have sufficient evidence to know whether a treatment really works, and importantly whether it works safely and without causing any harm.
Clinical trials allow us to see whether new treatments work and if they are safe. Patient safety is at the heart of trials; they are carefully planned and regulated to ensure this. In the UK, an independent Research Ethics Committee, and the Medicines & Healthcare products Regulatory Agency (MHRA) must approve every clinical trial before it can start.
- Are all clinical trials the same?
No. Whilst some trials are done to test the safety and effectiveness of new medicines for the first time, others may be done to look at new combinations of existing treatments. Trials may also be to test whether giving treatments in a different way can be more effective or reduce any side effects. If you decide to take part in a trial, the research team will explain in detail the purpose of the trial before the trial begins.
- What is a randomised control trial?
Trials are often used to compare a new treatment with a standard treatment already in use or with a ‘dummy’ (placebo). In these studies, patients are selected at random as to whether they will receive a new, standard or dummy treatment. It is important that the participant or researcher does not know whether they are receiving the new, standard or placebo treatment until the study is over.
- What will I have to do?
This will depend on what the trial is investigating. The research team will give you written information about what will be expected of you including an estimated length of the study. If you have any questions you can ask the research doctor to explain it to you.
If you are happy to join the research study you will be asked to give written informed consent in order to demonstrate that you understand what is expected of you and to confirm that you are happy to take part in the study. This will involve signing a form with details of the study, which the study team will provide for you. Once you have signed this form, you will receive a copy for your records.
Before giving informed consent it is important that you ask any questions about anything that is unclear.
- What are the benefits of taking part?
Taking part in a research study means that you will have more contact with medical staff than you normally do. During the trial, your treatment and progress may be monitored more closely than if you were not taking part in a research study..
Although sometimes the research may not help you personally, it may benefit others by providing information that will help to identify treatments for people with the same medical condition in the future. Many people take part in a clinical trial because the results can make a difference in the care of future patients by providing information about the benefits and risks of new medications. People who take part in clinical trials are vital to the process of improving medical care.
- What are the risks of taking part?
When designing a clinical trial, every effort is made to reduce and eliminate any risk factors. Any known risks will be explained to you by the study team before you agree to take part in the trial.
If you decide to participate in a clinical trial, it's possible you'll experience unexpected side effects. For this reason you will be monitored closely in order to detect any side effects or changes. If you take part in a research trial, it is important that you tell the research team about any illness or changes in health that you experience.
Another potential disadvantage is that you may have to visit your place of treatment more often, or have more tests, treatments or monitoring than you would if you were receiving the standard treatment in usual care. This is because it’s important for the research team to record as much information as possible about how you feel whilst you are taking part in the trial.
- Will my medical information remain confidential?
When taking part in a clinical trial, healthcare professionals other than your doctor will need to see your medical records. However, everyone follows the same confidentiality guidelines in according with the Data Protection Act.
Clinical trials often take place across several hospitals or even internationally and we may need to share information across sites. If this is required, your personal details will not be included.
- If I take part in a study, who will I see when I attend the CRF?
You will usually see a combination of doctors, research nurses and other healthcare professionals.
- Will I find out the results of the research study?
The research team can let you when the results of the study are available. Results may also be published but you will not be identified unless you have consented to this.
- How do I find out more about the research?
We encourage you to ask questions as it is important that you understand the research and what it involves before giving informed consent. Be sure to ask staff from the research team as many questions as you need before taking part in a trial.
Some common questions you might want to ask us include:
- How/why was I chosen?
- Is the research a clinical trial to test a new treatment?
- Is my treatment affected if I don’t get involved?
- If I change my mind, can I leave the study once I have started?
- How long will the research take and what will I have to do?
- If you are testing a new drug, how many people have taken it before?
- Are there any possible side effects?
- Who can I talk to if I have any questions, concerns or problems?
- Will I need to take time off work?
- Will I receive any payment for my time/ travel expenses?