Clatterbridge is a national leader in clinical research trials – some of our cancer studies are world firsts – and we have been awarded prestigious accreditations for the research we do.
By taking part in a clinical trial, patients receive cutting-edge treatment not currently available to the general public, so have the opportunity to help their own condition as well as furthering cancer research for other patients now and in the future.
A clinical trial is an investigation which looks at the safety, effectiveness, and potential benefits of a test or treatment. It may be scientific laboratory-based research or psychosocial, to understand how patients or carers feel or the impact of a procedure in clinic.
Examples of this could include a new drug or combination of drugs, medical device, vaccine, diagnostic test, or treatment procedure. These trials are essential for advancing medical knowledge and improving patient care.
Clinical trials follow carefully designed and controlled protocols that outline how the study should be conducted, and they are required to follow strict ethical and regulatory guidelines to protect the wellbeing of all participants.
As is the case with all medical procedures, there is an element of risk, but all Clatterbridge’s clinical trials go through many layers of testing and authorisation by national organisations before they are offered to patients. All clinical trials patients are closely monitored throughout their treatment, and afterwards, to minimise any problems that may arise.
Patients are only invited to join a clinical research trial if the medical team believes it can help them – and taking part is completely voluntary. Patients can leave the trial at any time, without the need to give a reason.
Phases and types of clinical research trials
Clinical trials of new treatments are typically conducted in phases:
Phase I: Involves a small group of patients and aims to assess the safety, dosage, and potential side effects of the intervention.
Phase 2: Expands the study to a larger group of participants with the specific condition or disease being targeted. This phase evaluates the intervention's effectiveness and further assesses its safety.
Phase 3: Involves an even larger group of participants and compares the new intervention with existing standard treatments or placebos (inactive substances). This phase provides more comprehensive data on the intervention's safety and effectiveness.
Phase 4: Takes place after the intervention has been approved for public use. It monitors the intervention's long-term safety and effectiveness in a larger population over an extended period.
Clinical trials can be interventional or observational. Interventional research studies often involve administering drugs, conducting procedures or testing devices within a patient population. There can be several different types of interventional drug studies such as randomised controlled trials, open label not randomised trials, blind trials, double blind trials and placebo-controlled trials.
Observational research studies often use non-interventional methods such as questionnaires, interviews, tissue or blood donation and data analysis to evaluate a technology, procedure or treatment. Examples could include a biobank of samples, quality of life research aimed at improving patients’ wellbeing and research into factors increasing individuals’ risk of cancer.
Are clinical trials always useful?
Clinical trials do not always result in new, better treatments. Sometimes trialled treatments do not work or have more side effects than existing treatment. However, this knowledge helps researchers and doctors to continue to find the most suitable options available in order to provide the best possible care for our patients.
Participating in a clinical trial
All patients who participate in clinical trials are volunteers and can choose to stop their involvement at any time without their standard of care changing.
A doctor or nurse will approach patients who may be eligible for a trial to see if they would like to take part. Patients must then complete in a process called informed consent to make sure that they understand what the trial involves and what the trial is trying to find out. The doctor and research nurse will provide a patient information sheet and give patients time to decide whether they would like to take part and ask any questions they may have.
If patients wish to participate in a clinical trial after learning about all that is involved, and what they would be expected to do, then they will need to sign and date the informed consent form. Patients are also able to enquire about potential clinical trials at any time.
The informed consent process does not end once patients sign the form. A patient is always asked if they are happy to remain on the trial at each visit with their clinician or care team. If new benefits, risks or side effects are found during a trial, the doctor must inform all of the participants in the trial.
Patients always have the option to withdraw their consent and stop taking part. If patients decide they do not want to take part in the trial, they can tell their doctor or research nurse. Patients do not need to provide a reason for not taking part and there will be no change in the standard treatment they receive.
After consent, participation in a clinical trial can look different depending on the type of trial, the patient’s medical diagnosis (eg cancer type) and the drugs involved. Patients involved in clinical trials are closely monitored at all times.
If you are a Clatterbridge patient and are interested in taking part in any of our clinical trials, please speak with your care team to see what trials are currently available. You can also follow this link for more information: Join in our research.
If you are not a Clatterbridge patient, we are not able to make referrals to clinical trials via direct telephone calls or emails to our hospitals or staff. Please contact your GP, consultant or surgeon to discuss the possibility of joining the clinical trial you are interested in. If you are eligible for a particular trial, your clinician can refer you to us and you will be contacted in due course.
To find out what clinical research trials are being conducted at The Clatterbridge Cancer Centre, go to our Find a Clinical Trial Or Research Study section.
Below, Clatterbridge patient Moira Griffiths-Parr talks about her experience of taking part in clinical research trials.
