What’s on this page?
- What are clinical trials?
- Why are clinical trials needed?
- Why take part in a clinical trial?
- What is Informed Consent?
- What approval does the trial need?
- How are Clinical Trials Regulated?
- How do I find out about clinical trials that are recruiting patients?
- What are the questions to ask when considering a clinical trial?
- What are the advantages of being in a clinical trial?
- What are the disadvantages of being in a clinical trial?
- Why might I not be able to take part?
- Who will look after me if I take part in a trial?
- What medical tests will I have as part of the trial?
- Can I leave a trial?
- What is it like being on a clinical trial?
The Rheumatology Departments at Royal Cornwall Hospital and at Derriford Hospital are active in research and currently have a number of projects in progress, all of which help to further our understanding of rheumatological conditions and may lead to the development of new treatments.
You may occasionally be asked if you would like to take part in a research study and we appreciate your help in this however, there is absolutely no pressure to participate if you prefer not to do so.
Below is some general information about clinical trials and what they involve. If you are interested in finding out more about clinical trials please speak to your consultant or rheumatology specialist nurse.
A clinical trial is a particular type of clinical research that is used to see if a treatment is effective and safe. It compares one treatment with another. It may involve patients or healthy people, or both. Small studies produce less reliable results than large ones, so studies often have to be carried out on a large number of people before the results are considered sufficiently reliable.
Doctors and other healthcare professionals and patients need evidence from clinical trials to know which treatments work best and are safest. Without this evidence, there is a risk that people could be given treatments that have no advantage, waste NHS and tax payers resources, and might even be harmful.
Clinical trials help to find out if:
- •treatments are safe
- •treatments have any side effects
- •new treatments are better than available standard treatments
Many NHS treatments have been tested in clinical trials.
The NHS aims to inform patients about research relevant to them and offer more patients the opportunity to take part in clinical trials, if they want to.
If you take part in a clinical trial, you may be one of the first people to benefit from a new treatment. However, it may turn out to be no better, or to be worse, than the standard treatment. Many people choose to take part in clinical trials because it helps increase understanding about a particular disease or condition. This may benefit them or others like them in the future.
The informed consent process ensures that the trial and potential side effects have been explained to you in full before you make a decision whether or not to take part. Before making the decision to join a trial, you should feel confident that you have been given all the information you need. The doctor organising your treatment will usually talk to you about being involved. They should explain the possible risks and benefits and will give you written information to take away with you. You will be given time to think it over and talk about it with your friends, family or GP. If you decide to take part, you will be asked to sign a form to say that you are agreeing to take part in a trial and have understood what that will involve. This is called giving your informed consent. It is always entirely up to you to take part. You are never under any obligation to take part and you can always choose the leave the trial at any time for any reason. You cannot enter a trial without having given your informed consent.
All clinical trials that take place in the UK must be approved by an independent ethics committee. An ethics committee is made up of local health professionals, patients & members of the public. The committee will review all aspects of the trial and it must be approved by the committee before it can proceed. The purpose of the ethics committees is to ensure that clinical trials are safe, worthwhile and protect the interests of those who participate in the study.
“The Medicines for Human Use (Clinical Trials) Regulations 2004” came into effect in May 2004. These Regulations help to ensure that the rights, safety and well-being of those who participate in clinical trial subjects are protected. They do this by requiring sponsors of trials to be responsible for designing, conducting, recording and reporting clinical trials according to internationally recognized principles of Good Clinical Practice. Clinical Trials are regulated by the European Clinical Trials Directive (Eu-CTD.) and medicines that are used in clinical trials are rigorously governed by the MHRA (Medicines and Healthcare Regulatory Authority.) The MHRA inspects research sites to ensure research is conducted in line with Good Clinical Practice. The Department of Health also ensures that research is properly governed. All researchers have strict guidelines to adhere to in order to comply with the regulations and are monitored during and after the trial period.
If you are interested in taking part in a clinical trial, ask your doctor or other health professionals if research is going on that may be right for you. The UK Clinical Trials Gateway provides easy to understand information about clinical research trials running in the UK, and gives you access to a large range of information about these trials. It is designed to enable you to find trials of interest to you. If you wish to join a trial you should discuss this with your doctor or clinical team.
The information is being taken from a variety of national registers that are publicly available. This means that it can include trials that may be run from other countries but which have part of the study taking place in the UK.
You can also find out about clinical trials that are on offer through Arthritis Research UK
There are a number of general and practical questions you may want to ask when considering entering a clinical trial:
The main reason for carrying out trials is to determine whether one treatment is better than another. An advantage of being involved in a trial is that you may be given a new treatment that is better for your condition.
During the trial, your treatment and progress may be monitored more closely than if you were receiving the usual treatment.
After the trial has finished, health professionals will be better able to offer you the most appropriate and effective treatment for you.
Trials are very important in helping find better treatments. By being involved in a trial, you will obtain information and evidence that may be helpful to you in the future, as well as helping the NHS to give people the best possible standard of care.
The disadvantages are:
- As with any treatment, you cannot be sure of the outcome.
- You may be given a new treatment that turns out not to be as effective as the standard treatment.
- It is possible that you will experience unexpected side effects.
- 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.
Sometimes, it is not possible for you to be involved in a particular trial. For example:
•Your condition may need to be at a particular stage.
•You may not be allowed to receive another treatment at the same time.
•Some trials seek people with certain illnesses and conditions, while others need healthy people.
•Some trials need people of a certain age.
•There may already be enough people in a particular category who have joined the trial.
You will see a number of people who make up the research team.
A research team is made up of doctors and nurses who specialise in research. They all have a special interest in Rheumatology and also the special area of research that is being studied. They also have good clinical experience of rheumatology. Very often they will be doing research in addition to their clinical work. At all times during studies the researchers work very closely with your rheumatologist and specialist nurses and GP’s, to keep them informed of what is going on. Their main focus of work is to ensure you receive the right level of care. You can discuss any anxieties and concerns you might have with them.
The type of medical test varies between trials. Before you join a trial, you may need to have tests to see if you can take part. For Rheumatoid Arthritis trials you may have:
- Blood tests to measure inflammation. For example, ESR and CRP. These tests are carried out regularly to assess disease activity
- Questionnaires e.g. Health Assessment Questionnaire (HAQ)
- Examinations of joints for swelling and discomfort
- Examination of joints by ultra sound
This will allow the researchers to know more about your health before you start treatment, so at the end of the trial they can tell if there’s been an improvement.
During the trial, you may have more tests to see whether the treatment is working. It may be possible for the tests to be carried out as part of your routine care, or you may have to make more visits than usual to your GP or hospital clinic.
You may decide to stop taking part in a trial if your condition is getting worse or if you feel the treatment is not helping you. You can also choose to leave at any point without giving a reason, and without it affecting the care you receive. If there are signs that the treatment in a trial could be unsafe, the research team or the regulators will stop the trial
Below is one patient’s experience of being in a rheumatoid arthritis clinical trial: