Research Studies Explained
Clinical trials are medical research studies involving people. They aim to test whether different treatments are safe and how well they work. Come trials involve healthy members of the public. Others involve patients who may be offered the option of taking part in a trial during their care and treatment. Clinical trials are carried out to try to answer specific questions about health and illness.
They aim to find the best ways to:
- prevent disease and reduce the number of people who become ill
- treat illness to improve survival or increase the number of people cured
- improve the quality of life for people living with illness, including reducing symptoms of disease or the side effects of other treatments, such as cancer chemotherapy
- diagnose disease and health problems
Clinical trials cover a broad range of different types of research. For example, trials are often used to test new medicines or vaccines but can also be used to look at new combinations of existing medicines. They 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 ways to prevent a particular disease in people who have never had the disease, or to prevent a disease from returning.
The treatments being tested in these types of studies can include vaccines, but may also involve drugs or dietary supplements such as vitamins and minerals.
Clinical trials are not always about testing medicines, they can be used to test ‘interventions’ aimed at modifying a person’s behaviour or lifestyle. This could include an educational programme designed to improve a person’s understanding of their medical condition and help them to manage it more effectively, of a psychological treatment, such as the use of cognitive behavioural therapy for the treatment of anxiety or depression.
Clinical trials are the most reliable way of testing new treatments or interventions. Potential new treatments might not always be better, and could even be worse than the existing ones. Only by rigorous testing is it possible to ascertain which ones are the safest and most effective which in turns allows continuous improvement in the quality of the care patients receive.
The inclusion criteria help the researchers to decide who can take part in the trial. Some trials include only people in a certain age group, or of one sex, or at a particular stage of their illness.
The exclusion criteria state who cannot take part in the trial. For example, many drug trials do not allow pregnant women to take part as there may be a risk to the unborn baby. People who are already taking particular medicines may also be excluded as the may affect the trial treatment.
Before you go into a trial you may have to have some extra tests to see if you are eligible or to ensure that you are not likely to be at risk of being harmed by the treatments in the trial. For example, if a potential side effect of a new drug is that it increases blood pressure you may have your blood pressure checked to see if you are eligible to join the trial.
Many of our patients who have taken part in research have found it a positive and rewarding process.
There is evidence that for some conditions, patients involved with clinical trials have better long term outcomes and may also get earlier access to new drugs.
Your health will be closely monitored throughout a clinical trial. Any changes in your health, whether or not they are related to the treatment you are having, are frequently picked up and acted upon earlier than if you were not in a trial. However, some people find that the extra attention makes them worry more about their condition.
If you take part in a research study you:
- will be helping others, and possibly yourself, by helping to identify more effective medical treatments
- will have more contact with medical staff than you normally do
- will have opportunities to learn more about your medical condition, which may help you to manage it better
- may feel as though you are taking a more active role in your healthcare.
A clinical trial is often run in a number of different hospitals or health centres. The doctor or nurse who asks you to take part in a clinical trial may not be the person who designed and set up the study, especially if it is very large.
However, they will have been fully briefed about the study before agreeing to become involved. They can give you all the information you need and will be able to answer your questions.
There are many types of trials carried out at the Royal Surrey County Hospital NHS Foundation Trust.
Prevention trials :- These test new approaches such as medications, vitamins or other supplements that might impact on the way diseases progress. Most prevention trials are conducted on healthy people, or with people who have had a disease and want to prevent recurrence.
Screening trials:- These are trials that look into ways of detecting diseases and conditions early, for example a trial looking at screening urine to see if it can be used to detect early bladder cancer.
Diagnostic trials:- These trials study tests or procedures that could be used to identify disease earlier and more accurately.
Treatment trials: These trials are conducted with patients who have a diagnosis of a disease or condition. The trials are designed to answer specific questions about, and evaluate the effectiveness of a new treatment or a new way of using a standard treatment.
Quality of life or supportive trials:- These trials explore ways to improve the comfort and quality of life of people with disease or conditions. Often these trials are incorporated within other trials.
Genetic studies: Often these are found within other trials to explore the genetic component of disease. The information from these trials looks at how genetic makeup can affect detection, diagnosis, or response to disease treatment.
A doctor, nurse or other research practitioner will always seek your permission to enter you into a clinical trial. They cannot enter you into the trial if you do not voluntarily give your informed consent.
There are a few exceptional circumstances where the consent process is different, and people might be entered into a trial without their initial consent. For example, in a trial of the treatment of stroke or dementia an individual may not be able to give their consent or similarly if a patient is sedated and receiving respiratory support. In these cases, consent may be obtained from a relative or other legal representative and there will be additional safeguards to protect the participants.
To help you decide whether you want to take part in a trial, the researcher will explain:
- the aim of the study – what it is trying to find out
- how you will be treated and what you will need to do
- what the possible risks and benefits are
- how long your participation in the study may last
It is important that you are satisfied that you have been provided with enough information to make a decision to give your informed consent.
You should feel free to ask any questions that are important to you in helping you to reach a decision. You should also feel satisfied that you have been given enough time to think about the trial and what it will mean to you.
The person inviting you to take part in the trial should first discuss the study with you and answer your immediate questions. They should also give you an information leaflet about the trial that you can take away and read in your own time. You may want to discuss it with your family or friends and consider any practical issues, such as extra appointments and tests.
If you decide that you do want to take part you will be asked to sign a consent form that says that you agree to join the trial and that you have decided to do so of your own free will. You will be given a copy of the signed consent form to keep. If English is not your first language, the trial will be explained to you in your preferred language where possible and you will also be given a consent form that has been written in your preferred language.
If you agree to take part in a clinical trial, any information that is collected about you will be kept confidential. This information will be stored safely and used only for the purpose of the trial.
You will be assigned a study number and it is this number that is linked to the trial database. Your name will not be disclosed outside the Hospital Clinic for the purpose of the trial.
We will often ask you for permission to let us contact your GP to let them know that you are taking part in a study.
Once the trial has finished the results are usually published and often presented at conferences. No name or any information that can identify you will be used in any reports about the trial.
The Royal Surrey County Hospital is active in a number of research areas, to find out what studies are currently open across these department please speak to your clinical team about the research that is available to you
Your doctor or nurse will inform you about the trials that are happening now during your consultation.
The Royal Surrey County Hospital may not run the trial for which you are suitable. With your permission ,your doctor would then refer you to another hospital . However , to participate in any study, you have to fulfil a list of specific requirements.
These are some of the questions you may like to ask before deciding whether to take part in a clinical trial.
- Why have you suggested I enter the study?
- What is the purpose of the study?
- What are the investigations I need to go through to enter the trial?
- How long will it take to get me into the study? Or to start treatment?
- Can I have my treatment at my local hospital?
- How often will I have to come to the hospital?
- Will my travel expenses be reimbursed?
- What happens if I want to withdraw from the study?
- Am I going to be given out of hours contact details?
- What is the alternative to the trial?