International Oncology trials are running in the BSHC since 1998 and in that time we have opened over 70 clinical trials and cared for over 700 patients. We are affiliated with Cancer Trials Ireland https://www.cancertrials.ie/, formerly ICORG. Oncology trials are essential for the progression of standard of care treatment and practices. Recent advances in Cancer therapy are the direct result of high quality, prospective research; clinical trials are consistently seen as a core component of optimal patient treatment. Patient’s voluntary participation in clinical trials has shaped the landscape of today's oncology service and will continue to do so in the future.
A clinical trial is a research study designed to evaluate treatments. The goal is to find safer and more effective ways to treat or prevent cancer. A clinical trial is also known as a clinical study, research study, or medical research.
Clinical Trials may be done to test one of the following:
Clinical trials are conducted in an orderly series of steps, called phases. This allows doctors to ask and answer questions in a way that results in reliable information about the treatment and protects the patients. Clinical trials are usually classified into one of four phases. In the Bon Secours Cork, we focus on Phase II and III trials, which are explained below.
Phase II trials: These studies follow the phase I trials and by this time doctors already know quite a lot about the treatment. A phase II trial continues to test the safety of the drug, and begins to evaluate how well the new drug works and for which types of cancer it might be useful. These studies involve more patients, between 100-300.
Phase III trials: These studies follow the phase II trials and the aim is to compare a new drug or a new combination of drugs in comparison to the current standard treatment. Phase III trials often enrol large numbers of patients (1000-3000) and may be conducted at doctors' offices, clinics, and cancer centres worldwide.
Today's clinical trials lead to tomorrow's standard treatment. The information obtained from a clinical trial advances our progress in the fight against cancer. Without clinical trials, and without the assistance of patients willing to enrol onto these trials, our treatments for cancer would never improve.
What is standard treatment? Standard care is a treatment option that has been proven effective and is currently being used. Today's standard treatments were first shown effective in clinical trials in the past.
Patients participate in clinical trials for many reasons, usually hoping for a better treatment or cure. However, there are no guarantees but doctors who conduct clinical trials believe the new treatment will provide benefits equal to or better than the current standard of care. The advantage of participating in a clinical trial is that you may be one of the first to benefit from the latest cancer treatment. Patients in clinical trials receive close medical follow-up during and after the trial. Many patients feel a greater sense of purpose by participating in a clinical trial as many of the treatments that we now benefit from, started as a clinical trial less than a decade ago.
Clinical trials are carefully designed to minimize the risks and maximize the benefits to all the people who take part, regardless of which treatment they get. A trial treatment as well as standard treatment has side effects. Since clinical trials are studying new treatments, not all the side effects may be known ahead of time. You may not always receive the new treatment or the new treatment may not prove to be any better than standard treatment. Even if the new treatment is effective for some people it may not be as effective for you. When you take part in a trial you will be monitored carefully during and after the study. You will have regular tests and you may be asked some extra question about how you are feeling. Sometimes this means going to your hospital or GP more often than you would normally. Although this may inconvenient, these tests only lead to you being observed more closely.
Each study has its own guidelines called eligibility criteria. Inclusion criteria may consist of things like disease type, medical history, age, gender and other factors necessary to join the trial.
Patient suitability - It is important to remember clinical trials are not suitable for all patients. Whether you are accepted will depend on your age, medical history, the stage of your cancer, your general health and the results of your blood tests. As part of the trial you may be required to attend Bon Secours regularly. This may mean coming to the Hospital on a weekly basis for blood tests. Ask how often you will need to come to the hospital and decide whether you can cope with this amount of travelling.