What happens in clinical trials and are they safe?

What is a clinical trial? A clinical trial is a study into the safety and effectiveness of a drug not yet licensed or a drug already on the market to test its effectiveness in the treatment of a different illness or the same illness at a different stage.

For example, researchers in Ireland participated in a European trial of the breast cancer drug, Taxotere, to test whether it would be a beneficial treatment in early stage breast cancer.

Its role in advanced stage breast cancer had already been proven. Taxotere has since been licensed as a treatment for early stage breast cancer in the United States and results of the European study are expected next year.

How are people chosen to go on clinical trials?

Generally speaking, there are two types of clinical trials. Those involving patients who may gain from participation and those involving healthy individuals.

Clinical trials proceed through four phases and in each phase larger groups of people are used to evaluate the safety and effectiveness of the drug.

As the standard approach to investigating a drug's effectiveness involves testing it against a placebo (a substance which has no pharmacological effect), two groups of volunteers are required.

Often, hospital-based researchers will ask patients if they are interested in being involved in a trial for a new drug whose effectiveness is being tested for their specific illness.

Patients must be informed that they will have no knowledge as to which group they will be assigned and often researchers are also kept in the dark regarding which patient group has been given a placebo and which group has been given the drug.

What are the benefits of being on a clinical trial?

The benefits for patients with a serious illness for which there is no current cure is that they might find their condition improves while they are on the clinical trial for the new drug. Healthy volunteers are often paid.

What are the risks of going on a clinical trial?

Before it begins, a clinical trial must by approved by the Irish Medicines Board (IMB) and a research ethics committee recognised by the Department of Health. The biggest risk of being on a clinical trial is that a patient can have serious adverse reactions to the new drug. When this happens, the research team must immediately alert the IMB, the ethics committee and an independent data-monitoring committee so a decision can be made as to continue or halt the trial.

What supports are in place for volunteers before, during and after a clinical trial?

Volunteers must give their informed consent before taking part in a clinical trial. Volunteers participating in a clinical trial are usually assigned to a research nurse who they can contact at any time during the trial.

What happens if a clinical trial is stopped before its completion?

Patients are informed in detail as to why the trial has been stopped and returned to their standard treatment. They are given thorough medical examinations and follow- up examinations where appropriate.

To date, there is no standard access to counsellors for patients to discuss possible fears and disappointments arising from the clinical trial being stopped.