For Patients Q&A

Working in collaboration with your Consultant to bring you access to clinical trials. 

The Wellcome HRB Clinical Research Facility (CRF) aims to provide our patients with access to new treatments that would not be available to them outside of a clinical trial setting.

The CRF has been in operation since 2013 and over that time we have enrolled hundreds of patients onto clinical trials and non-regulated studies. We work with most of the large pharmaceutical companies as well as many research network groups nationally and internationally.

We conduct trials in:

We are staffed by a highly-skilled team of research nurses, data managers, a clinical trials pharmacist. The clinical director is Professor Martina Hennessey, Clinical Pharmacologist.

1.
How to access this service

If you are a patient of St James’s Hospital, please ask your doctor if there is a trial suitable for you.

If you are a patient at another hospital and you are interested in a trial that is open here, then please ask your doctor to refer you to the doctor at St James’s Hospital who is conducting the trial.

2.
What is a clinical trial?

Clinical trials are medical research trials involving research on a particular disease area using a medicine. Clinical trials aim to improve treatments for patients and enhance their quality of life.

Most trials involve testing a new type of  drug or method of treatment. Every trial is led by a medical doctor and a research team who will look after you during your treatment. Our team here in the CRF is highly skilled and will provide you with the care and support you need.

There are several phases of clinical trials:  Phase 1, Phase 2, Phase 3 and Phase 4. Most clinical trials are randomised and they involve two or more treatment arms; this means that you will be randomly assigned to one of the treatments.

Randomisation ensures that the trial is fair and that the results are reliable. You may not be assigned to the new treatment arm and this might disappoint you.

Some trials may involve a placebo. A placebo can look like a real drug but it does not affect the body. Placebos are used when there is no standard treatment to compare the new treatment to. Clinical trials are highly regulated and follow a long and careful research process to make sure they are as safe as possible.

3.
Who can take part in a clinical trial?

All trials have guidelines about who can and cannot take part. These are sometimes called eligibility or inclusion criteria. For example, a trial may only include people with a certain type of disease  or a certain age group. Trials also have guidelines about who cannot take part. These are called exclusion criteria.

Your  doctor or research nurse can tell you if a certain trial is suitable for you.

4.
If I am interested in participating in a trial, what is the next step?

If you are interested in participating in a clinical trial, then please ask your  doctor if there are any suitable trials for you. If there is a suitable trial, then you will be provided with a patient information leaflet (PIL) and informed consent form.

This is a detailed document that tells you everything about the trial. The trial will be fully explained to you by your doctor and research nurse.

You will be advised to take the PIL home and discuss it with your family and friends and a follow-up appointment will be made for you.

When you attend for the follow-up appointment, the trial will be discussed again and if you wish to participate then you will sign the informed consent form.

You will then be ‘screened’ for the trial; this involves various tests and assessments and this may take a few weeks. If you are deemed eligible, then you will be randomised to one of the treatment arms on the trial and your treatment will commence.

5.
How will I benefit?

Taking part in a trial means you may benefit from a new treatment that might not be available, except in the trial setting. The new treatment may work better than the standard treatment.

You will be closely monitored throughout the trial by the research team and there will be a research nurse that you can liaise with. Whilst you are on a clinical trial you may have to attend the hospital more frequently and have more frequent blood tests or scans. Some patients find this reassuring.

6.
Are there any risks or drawbacks?

With any trial, there is a small risk that the treatment could harm you or not work. You could get unpleasant or unexpected side effects, which is important to report to your study team. During the trial, researchers try to reduce these risks as much as possible.

Taking part in a trial may involve additional visits to the hospital which may be an inconvenience for you and your family.

7.
Will it cost me anything to participate in a clinical trial?

There will be no additional costs to you. Any additional tests associated with the trial will be paid for by the trial sponsor. You may have to visit the hospital more frequently as part of the trial and in this case, your travel expenses may be reimbursed. Please talk to the research nurse about this.

8.
How long do trials last?

Clinical  trials can last from one year to many years. Depending on the phase of the trial there may be hundreds or even thousands of patients enrolled on it at many hospitals all over the world.

Your participation in the trial may last for several years as we will continue to follow-up with you long after your treatment has stopped.

9.
Can I withdraw from a trial?

You are free to withdraw from a clinical trial at any time. Your participation is entirely voluntary. You will need to inform your research team of your desire to withdraw and they will discuss other treatment options with you. Your decision to withdraw will not affect your future care.

10.
What about non-regulated studies?

The CRF is involved in regulated studies as discussed in the questions above and also involved in non-regulated studies which  could be disease registries, biobank type studies, physiotherapy interventional studies.

11.
What is a biobank?

Watch our video below to find out more