Clinical Trials FAQs
What is a clinical trial?
A clinical trial is also known as a medical research study. It is a carefully designed test of medicines and treatment options under the supervision of a doctor.
Who can participate in a clinical trial?
Clinical trials rely on people, referred to as study participants, to try the new medicine or treatment. Any participation is voluntary.
Each clinical trial defines who is eligible to take part in the study and must include only people who fit the patient traits for that study (the eligibility criteria). Some trials enrol people who have a specific disease or condition. Others enrol healthy people to test new approaches to prevention, diagnosis or screening.
What is the aim of a clinical trial?
Clinical trials are designed a medicine or treatment that is described as “investigational”. This means it is being tested to determine how well it works and/or what side effects it may cause. In some clinical trials, the medicine being studied is already used by doctors but is in a clinical trial to test it for a new disease, new dose or in new combinations.
How are clinical trials different from standard clinical care?
If you take part in a clinical trial, you will still have tests or treatments in a hospital, clinic or doctor's office. However, you may have more tests and medical exams than you would otherwise.
The purpose of clinical trials is research, so the studies follow strict scientific standards. These standards protect patients and help produce reliable study results.
How are clinical trials regulated?
Every study participant is closely monitored with medical tests and examinations before, during and after the clinical trial.
In addition, clinical trials must follow strict rules set by the Medicines and Healthcare products Regulatory Agency (MHRA), an executive agency of the Department of Health.
Each trial must be approved by an Ethics Committee (EC) in the UK. An EC is an independent committee of healthcare professionals and non-medical members. Before the study goes ahead, the EC makes sure that it is ethical and that the highest standards of safety will be maintained.
What are the different types of clinical trials?
Clinical trials involving new drugs are commonly classified into four phases. Clinical trials of drugs may not fit into a single phase. For example, some may blend from Phase 1 to Phase 2 or from Phase 2 to Phase 3. Therefore, it may be easier to think of early phase studies and late phase studies.
The drug development process will normally proceed through all four phases over many years. If the drug successfully passes through Phases 1, 2 and 3, it will usually be approved by the national regulatory authority for use in the general population. Phase 4 are 'post-approval' studies.
Why should I participate in a clinical trial?
Individuals participate in clinical trials for a variety of reasons including access to new treatments before they are widely available, advancement of science or improved medical care. Study participants can benefit greatly from clinical trials by receiving access to the most promising investigational cancer treatments available. This helps in the possible development of a new medicine or treatment that may offer better care or a cure for life-threatening and chronic diseases.
Whatever your reason for participating, you can be sure you will receive quality cancer care while on a clinical trial.
What happens during the trial ?
This depends on the trial itself, but all the details of the visit schedule and trial procedures will be explained to you in detail before you agree to take part.
All our clinical trials are conductedin a high quality, calming environment which can greatly reduce any anxiety that may be related to cancer treatment. Staff treat patients in a friendly, down-to-earth manner and we want patients to feel as comfortable, relaxed and supported as possible in our treatment suites. To achieve this we have created light and spacious individual areas which can be curtained off for privacy, or left open if desired. Each of these areas is equipped with screens where the internet or multiple TV channels can be accessed. A range of carefully selected light meals which are prepared in our own kitchens are available. Menus are designed with the dietitcian to be as enticing as possible to encourage patients to maintain vital nutritional intake during treatment.
We have prepared this FAQ Document to provide additional information that may be helpful during your participation in one of our clinical trials:
What if I am not suitable for a trial or I chose not to participate?
You may decide at any stage before or once treatment has started that you no longer want to participate. You do not need to give us a reason why, although we are always happy to discuss the matter with you.
Sometimes patients referred to us are not suitable for trial, this may be for a number of reasons. Our research team will discuss this with you and you will usually be referred back to your GP or oncologist.
“Participation in a clinical trial is the first step in fighting cancer, not the last.” ®