FAQs About Clinical Trials

Below are some frequently asked questions and answers about clinical research and trials.  If you have any other questions please email the Clinical Trials Volunteer Recruitment Manager, Reshma Sultan.

What is clinical research?

What is clinical research?

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.

Why are Clinical Trials important?

Why are Clinical Trials important?

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.

What can clinical trials find out?

What can clinical trials find out?

 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.

 

What is a randomised control trial?

What is a randomised control trial?

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.

 

What do I have to do?

What do I have to do?

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.

What are the benefits of taking part?

What are the benefits of taking part?

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.

What are the risks?

What are the risks?

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.

 

Is my information confidential?

Is my information confidential?

When taking part in a research study, people other than your doctor will need to see your medical records. However, everyone who sees your records will follow the same confidentiality guidelines as all other hospital staff, in accordance with the Data Protection Act. Sometimes research is carried out nationally across several hospitals or even internationally and we need to share the information about how the study is progressing. If we send information to other researchers, your personal details will be not be included to protect your confidentiality.

Who does the research?

Who does the research?

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.

 

Will I be able to see the results?

Will I be able to see the results?

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. 

How do I find out more about the research?

How do I find out more about the research?

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?