Clinical Trials Unit

A clinical trial is a research study designed to evaluate new treatments or a new way of using known 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:

• New treatments
• New ways of using treatments already available
• New combinations of existing drugs
• New ways of diagnosing or preventing cancer
• The psychological effects of the treatment

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 three phases.

Phase I trials:  The aim of phase I clinical trials it to find out how a new drug should be given (by mouth, injected into the blood, or injected into the muscle), how often, and how much of the treatment can be given without causing serious side effects. Doctors assess whether the side effects are acceptable in relation to the potential benefits. A phase I trial usually enrols only a small number of patients, between 20-80.

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.

Before you take part in a clinical trial you will be required to give your consent. If you agree to take part in a research project or clinical trial, you will be given written information about the trial and asked to sign a consent form. You should not sign the form until you are happy that all your questions have been answered and you fully understand what will happen to you as part of the trial. It is important to remember that once you have made a decision about treatment, you can change your mind at any time, even after you have signed a consent form. The consent form will include details about: · Purpose of the study · Background information about the treatment · How the treatment will be given and for how long · The possible benefits and drawbacks · Confidentiality of your medical information Informed consent continues as long as you are in the study. You should always feel free to ask the doctor or research team any questions you have at any point.

What is a protocol? A protocol is a study plan on which all clinical trials are based. The medical team uses the treatment protocol to safeguard the health of the participants as well as answer specific questions.

How is your treatment chosen? The Central Study Office will choose which treatment you will receive within the clinical trial. This is done randomly i.e. like the toss of a coin. Each participant has a fair and equal chance of receiving either treatment.

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 hospital regularly. This may mean coming to the Cork University 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. 

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.