The Cancer Clinical Trials Office (CCTO) aim to provide our patients with access to new treatments that would not be available to them outside of the clinical trial setting.
The CCTO has been in operation since 2003 and over that time we have enrolled hundreds of patients onto clinical trials. We work with most of the large pharmaceutical companies as well as many cancer research groups across Europe and North America.
We conduct trials in:
We are staffed by a highly-skilled team of research nurses, data managers, a clinical trials pharmacist and a team manager. The clinical director is Professor Elisabeth Vandenberghe, Consultant Haematologist.
If you are a patient of St James's Hospital, please ask your cancer doctor if there is a trial suitable for you.
If you are a patient at another hospital and you are interested in a cancer trial that is open here, then please ask your cancer doctor to refer you to the doctor at St James's Hospital who is conducting the trial.
Cancer clinical trials are medical research trials involving patients with cancer. Cancer clinical trials aim to improve treatments for cancer and give patients with cancer a better quality of life.
Most trials involve testing new chemotherapy drugs, surgery and immunotherapy. Every trial is led by a medical doctor and a research team who will look after you during your treatment.
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 arms.
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. Cancer trials are highly regulated and follow a long and careful research process to make sure they are as safe as possible.
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 cancer and stage of cancer or a certain age group. Trials also have guidelines about who cannot take part. These are called exclusion criteria.
Your cancer doctor or research nurse can tell you if a certain trial is suitable for you.
If you are interested in participating in a clinical trial, then please ask your cancer 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 cancer 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.
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 and CT scans. Some patients find this reassuring.
With any trial, there is a small risk that the treatment could harm you. You could get unpleasant or unexpected side effects. 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.
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.
Cancer trials typically last for 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.
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.