ICTUImperial Clinical Trials Unit

Welcome to Imperial Clinical Trials Unit (ICTU)

This website is intended for people who are considering taking part in clinical trials and would like to find out more about what’s involved, why clinical trials are important and what the benefits of taking part in trials are. You can also find out about current clinical trials going on in ICTU and how to get involved.

FAQs

What exactly would I be asked to do?

The goal and therefore the steps involved in every trial is different. Before agreeing to take part in the study, your doctor will explain all of the steps, including what treatment (if any) you would receive during the study. Usually you would be expected to attend the study centre (hospital or GP practice) a number of times during the study. The actual number of visits will vary from study to study but you will always be seen promptly and as far as is possible, on a day/time that is convenient for you

Would I know exactly what treatment I was going to have?

Before deciding whether or not to take part in a study, the full details of all treatment which you may receive during the study will be explained to you. Most interventional trials involve comparing two or more different approaches to preventing or treating a medical condition, for example in a trial comparing treatment A and treatment B, 50% of people might be randomly assigned to treatment A and 50% would get treatment B. All study plans (protocols) must be carefully reviewed by a committee of experts and lay people to ensure that based on current knowledge, all treatments offered in the trial are adequately effective and safe. When deciding whether or not to take part in the trial, you generally won’t know which treatment type you would receive. In some studies, in order to make sure the results of the study are not biased by anyone’s opinions of either treatment, the patient or the doctor (or both) will not know until the end of the study which of the two treatments they are taking (this is called blinding).

Would I get information on any possible risks?

Before deciding whether or not to take part in any clinical trial, your study doctor would give you detailed information on all the known risks associated with the study treatments and answer any questions you may have. You will also be given time to think about the information you have received

How long would the trial go on for?

The duration of a clinical trial depends on exactly what question the study is trying to answer and also what medical condition is being studied. Some trials might only need your participation for a day while others might involve follow up for several years. A trial looking at the best treatment options for relieving a migraine headache or for finding out whether patients prefer a novel injection device to normal injection needles to inject their insulin would be short because you can see the results instantly. On the other hand a trial investigating whether doing exercise regularly can prevent heart attacks would be long because you would need to follow people up for several years to see if they have any heart attacks.

Would I be paid for taking part in a trial?

This depends on what kind of trial it is. For patients with a specific condition who taking part in a trial for the treatment of that condition, it is not ethical to pay them for taking part. However you will be reimbursed for any expenses incurred in taking part in the trial, such as travel and sometimes meal allowances.

Some trials require healthy volunteers who don’t have a particular condition that needs treatment but who are willing to take part in order to find out more about drugs in early stages of development. People willing to take part in these studies would normally paid because this is not part of their medical treatment.

Could I change my mind half way through if I decided I no longer wanted to be in the trial?

You will always be free to decide to opt out of a trial at any point for any reason. It's just important to let your study doctor/nurse know as they may wish to stay in touch with you to monitor your health even if you have decided not to continue in the trial.

Would I find out the results at the end?

It is only right that people who give their time and commitment to taking part in a study can find out the results at the end. All patients taking part in a study should be provided with the overall study results on request as soon as these have been published

Who would I contact if I had any questions or concerns during the trial?

You will always be given contact numbers of a person to call if you have any questions or concerns day or night while you are a participant in a clinical trial.

Will my personal information remain confidential?

When taking part in a clinical trial, 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 and GP practices 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 in order to protect your confidentiality.

How can I find out more about a study I am thinking of taking part in?

Before deciding to take part in a study, it is important that you feel you fully understand what is involved before deciding it if it is right for you. The study doctor/nurse will do their best to try to explain the study as clearly as possible, including giving you written information you can take away and read.
However you should never feel embarrassed to ask more questions about anything which you would like to know. For instance you might want to ask the study doctor/nurse or your own GP some of the following:

What is the aim of the study?
How/why was I chosen to take part in it?
What will be different to the treatment or care I would normally receive?
How long will the research take and what will I have to do?
Is the research a clinical trial to test a new treatment or compare two treatments already being used?
If you are testing a new drug, how many people have taken it before?
What are the possible side effects?
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?
What happens if something goes wrong?
Will I receive any payment for my time/ travel expenses?
Will I need to take time off work?
Is my treatment affected if I don't get involved?
Who can I talk to if I have any questions, concerns or problems?