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Clinical Trials

What is a clinical trial?

Researchers are continually refining current treatments or discovering new medicines to treat cancer and other diseases. A clinical trial is the term used to describe a scientific research study, which looks at different aspects of patient care, with the aim of improving the outcome compared to current practice. If early work suggests that a new treatment might be more effective than the standard treatment, doctors will need to compare the new treatment, with the best available standard treatment.

The clinical trial may look at using new drugs or combinations of currently used drugs to treat a particular illness. Alternatively, the trial may look at refined surgical techniques, medical devices or physical therapies. Clinical trials are the only way to improve the treatments for cancer, and giving patients with cancer a better quality of life.

Clinical trials can be divided into the following types

  • Trials designed to detect cancer, especially in the early stages
  • Trials designed to prevent cancer occurring
  • Trials designed to evaluate new treatments for patients with cancer
  • Trials to prevent new-cancers developing in patients who already have cancer
  • Quality of life studies, to improve the comfort and quality of life for patients living with cancer

Participating in a clinical trial

When you first attend the hospital or at some time while you are receiving treatment, you may be asked to take part in a research study or clinical trial. During any trial, you will see your doctor and other staff caring for you regularly, and your progress will be carefully followed.

Before entering you onto any clinical trial, your doctor must have your written consent and explain to you why the trial is being conducted, and why you have been invited to take part.

The possible benefits and drawbacks of participating in the trial along with any other available treatment will also be discussed with you.

The advantages and disadvantages of participating in a clinical trial
Many patients feel a great sense of purpose when participating in a clinical trial, as many of the treatments that we now benefit from started as clinical trials less than a decade ago.

The advantage of participating in a clinical trial is that you will be the first to benefit from the success of a new treatment if it proves to be superior to an existing one. You will also probably be seen more frequently than patients not participating in a clinical trial.
The disadvantage of participating in a clinical trial is that there may be extra hospital visits required.

If you are considering participating in a clinical trial, you should be aware that, depending on the type of trial and the stage it is at, you may be part of a control group and may not receive the new treatment. However, it is important to bear in mind that the new treatment may not prove to be any better than current therapy anyway. Therefore your participation, whether in a control group or as a patient receiving the new treatment, is equally important to the trial.

It is well recognised that patients participating in duly approved cancer clinical trials receive state of the art treatment and frequently have better results compared to patients who are treated outside of such a trial.

What happens in a clinical trial?

The clinical trail is only one stage in a long series of tests and trials, which each treatment must be put through in order to assess its effectiveness. In a clinical trial, all patients are either given the new treatment that is being evaluated, or are given the best standard care available. Neither the patient nor doctor and nurses involved in the clinical trail know which patients are assigned which treatment. This is to ensure that any benefit demonstrated by the new treatment compared to current practice, is unbiased.

Patients in a clinical trial are almost never given a placebo treatment. They are either given the new treatment under study or given the current best medical care. If no current treatment is available for a condition and a placebo treatment is to be included in the study, you will be informed of this fact before deciding to enter the trial.

Even after agreeing to take part in a trial, you can still withdraw at any time if you change your mind. Your decision will in no way affect your doctor’s attitude to you. If you choose not to take part or withdraw from a trial, you do not have to give any reason, your doctor and nurses will understand. In this case you will still receive the current best treatment available.

How long does a clinical trial take?

Clinical trials are currently ongoing in Irish hospitals to evaluate many different treatments. These trials are co-ordinated with other similar trials conducted worldwide. The length of a trial will vary depending on what questions the trial is trying to answer. Some trials may last a few months, while others can last for several years. In some cases it can be a number of years before the results are known, and this can be frustrating. However, this is due to the rigorous testing that all treatments must undergo before being adopted.

If you are eligible for inclusion in a clinical trial, then your doctor will inform you of this. If you are not aware of any clinical trials being conducted into treating your particular condition, then ask your doctor about this option.

For further information on Clinical Trials in Ireland, visit the ICORG The All Ireland Cooperative Oncology Research Group website (www.icorg.ie).

Page last updated: January 04 2010

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