Clinical research is a branch of medicine that looks at the safety and effectiveness of drugs, medical devices, treatments and diagnostic tools planned for use in humans.

Clinical trials look at new ways to prevent, detect, or treat disease. Treatments might be new drugs or new combinations of drugs, new surgical procedures or devices, or new ways to use existing treatments. The goal of clinical trials is to see if a new test or treatment works and is safe.  It may involve patients or healthy volunteers, or both.

Before a treatment can be prescribed we need to know whether it works, whether it works better than other treatments currently used and if it has any side effects.

Clinical trials are designed to answer these questions, leading to better health and quality of life for patients.  Involving people in clinical trials allows us to see whether the new methods are effective and safe.

Trials are very carefully planned and regulated to ensure that patient safety is at their heart.  Without them, there is a risk that people will be given treatments that don’t work, or could even be dangerous.  Many NHS treatments have been tested in clinical trials.

 Clinical trials help us find out what treatment works best for treating illnesses.  Treatments could include:

• new drugs
• vaccines
• surgery
• radiation treatment
• physical and psychological therapies
• educational programmes
• new ways of diagnosing diseases.

Not everyone receives a new treatment in a clinical trial, as we often need to compare a new treatment with a standard treatment already in use, or with a ‘dummy’ treatment known as a ‘placebo’.  In many studies, patients are selected randomly, by a process like flipping a coin, to receive a new, a standard, or a dummy treatment. It is often important that the participants and researchers don’t know who is receiving which treatment until the study is finished.

Your involvement, and the time that each study takes, will depend upon what is being investigated. The information given to you by the research team will include details of the estimated length of the study and what will be expected of you. If there is anything you do not understand you should ask the researcher to explain it to you.

If you are happy to get involved in a research study you will need to give informed consent, to show that you understand what is being asked of you and to confirm you agree to take part. You should not give your consent if you are unclear about any aspect of the research.

If you take part in a research study, you will have more contact with medical staff than you normally do and there will be opportunities to gain information about your medical condition, which may help you to manage it better.

In many cases, the research will not help you personally, but it may provide vital information that will help people in the future.

When a clinical trial is designed, every effort is made to eliminate any risk to patients, and the ethics committee will also check this. Each study will be different and so the risks will vary. Any known risks will be explained to you by the research nurse or clinician who enrol you on to the clinical trial.

The doctors and research nurses responsible for the research will monitor participants very carefully to detect any side effects and changes. If there are changes, medical staff will act immediately. If you are taking part in a research study, it is important to tell us about any illnesses or changes in your body that you notice.

As a Clinical Research Facility, we use personally identifiable information to conduct research to improve health, care, and services. As a publicly funded organisation, we have to ensure that it is in the public interest when we use personally identifiable information from people who have agreed to take part in the research.  This means that when you agree to take part in a research study, we will use your data in the ways needed to conduct and analyse the research study. Your rights to access, change or move your information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate. If you withdraw from the study, we will keep the information about you that we have already obtained. To safeguard your rights, we will use the minimum personally identifiable information possible.

Health and care research should serve the public interest, which means that we have to demonstrate that our research serves the interests of society as a whole. We do this by following the UK Policy Framework for Health and Social Care Research. For more information visit: https://www.hra.nhs.uk/information-about-patients/

If you wish to raise a complaint on how we have handled your personal data, you can contact our Data Protection Officer who will investigate the matter. If you are not satisfied with our response or believe we are processing your personal data in a way that is not lawful you can complain to the Information Commissioner’s Office (ICO).

Our Data Protection Officer is Mr Phillip Robinson and you can contact them at imperial.dpo@nhs.net.

This will depend on the study, but at the Imperial CRF it is likely to be a combination of doctors, specialist research nurses, other healthcare professionals or students under supervision.  You will be told who will be carrying out the research and who is funding it.

The researcher should tell you when the research is complete and the results are available.  Results should always be made public and this may include articles in medical journals or on websites. Some researchers also create a participant’s version of the results and you should ask your research team about this if you are interested. Findings from research studies are often also publicised in the media.

Never feel embarrassed to ask questions, as we want to make sure you fully understand the research and what it involves before you sign the consent form to take part in any study.

Some of the questions you might want to ask us, or other healthcare professionals such as your GP, include: 

• What is the aim of the study?
• How/why was I chosen?
• Is the research a clinical trial to test a new treatment?
• Does the research involve collecting samples of my cells or tissues?  If yes, what will happen with them and can they be used for other research projects?
• 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?
• What will be different to the treatment or care I would normally receive?
• If you are testing a new drug, how many people have taken it before?
• Are there any possible side effects?
• What happens if something goes wrong?
• 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?

The Imperial Clinical Research Facility (ICRF) is part of Imperial College Healthcare NHS Trust, and we rely on several NHS systems and procedures to support our research. To include you in a study, we need to record information in your medical healthcare record, both when you are a patient or a healthy volunteer.

Healthcare records at ICRF are mostly in electronic format and will include laboratory test results (including where required, test results for sexually transmitted infections / communicable diseases such as HIV), radiological imaging (e.g. ultrasound scans, X-rays, MRI etc), clinical notes, routine observations, prescription charts (a list of medicines given to you) and other study-specific information which is collected as part of the research. Such information may be valuable to support your health care now, or in the future. If you are not already a Trust patient, we will need to register you on the Trust records system.

Although information collected as part of this study will be available in your medical records, a duty of confidentiality applies, and staff within the NHS may only access your records if they have a legitimate reason to do so. If you have any concerns about this, please speak with your study doctor.

You are entitled to access NHS health records that we hold about you at ICRF, but this is managed centrally by Imperial College Healthcare NHS Trust, to whom you would need to apply for access. For further information and to apply for access, please visit the Trust website: https://www.imperial.nhs.uk/patients-and-visitors/patient-information/my-records

During your participation in a study we might find a previously undiagnosed illness, or detect something which is abnormal and potentially clinically significant (known as an ‘incidental finding’). ‘Clinically significant’, means the doctor believes there might be important implications for your health (including reproductive health). Minor abnormalities are common, and would usually not be considered clinically significant, so would not constitute an incidental finding. Incidental findings might be handled differently depending on the study in which you are participating, so you should refer to your participant information sheet for full details, or ask your study doctor if it is unclear.

We would always endeavour to inform you as soon as possible of incidental findings and discuss the implications and options available. We may refer you to your GP or another clinician for follow-up if appropriate, but would discuss this with you first wherever possible. As a result of incidental findings you might need to be withdrawn from the research study. If there was an incidental finding with serious implications for your health we would have a duty of care to inform your GP even if we were unable to contact you. There are also some notifiable diseases, which we are legally obliged to report to health authorities to help protect public health.

If a possible malignancy (cancer) is detected, your images will be reviewed by a multi-disciplinary team of experts from Imperial College Healthcare NHS Trust who will attempt to make a diagnosis and recommend a plan for treatment. This is done automatically to ensure that it is dealt with urgently, and may happen before we have been able to contact you.

It is important to us that you are fully informed so that you can make decisions for yourself about taking part in research at ICRF. We will do our best to communicate with you openly and clearly, so please ask questions at any time if there is anything that you’re unsure about.