Clinical Trials

What are Clinical Trials?

Clinical trials are research studies involving patients. They compare new treatments with old ones, or more often, new combinations of existing treatments, or a change in the way the existing treatment is given.
In clinical trials there are several terms used to describe the trial. Some of these terms are described here. They include:

• Randomised trial
• Blind trial
• Placebo

If you take part in a Randomised trial you will be allocated a treatment usually by computer. Trials are conducted this way to ensure that there is an even spread of patients between the treatments. This ensures that there is no favouritism, for example, elderly people given one treatment. It helps to ensure that the results are only due to treatment and not a specific factor, for example age.

A Blind trial is when the patients and the Hospital staff are not aware which treatment the patient is receiving. Trials are blinded to make sure that neither the Patient nor the Hospital staff influence the reporting of side effects or results. Sometimes if a person feels very positive about a treatment, it may affect the results. Blinded trials avoid this. They ensure that the results are accurate and any side effects
are purely due to treatment. You may also be offered a trial that involves a placebo.

A Placebo is a fake tablet, made of either sugar or salt. Placebo drugs are used in blind trials so that neither the patient nor staff knows which treatment they are receiving. Again this is to make sure that the
effects of the treatment are reported without preference or influence.

Why Do Trials Exist?

Trials are carried out in order to find out if the new drug, combination or administration method would be more effective or have fewer side effects. Drugs used in the trials have already been through rigorous laboratory tests. Through entering a clinical trial you would be helping to improve our understanding of disease and how to treat it.

Risk and Benefits

Trials are carefully designed to minimise risks. If you take part you would be monitored carefully during and after the treatment and have regular check ups. It is possible that patients who enter clinical trials may benefit by receiving the new treatment. The trials are designed with the belief that the trial treatment is at least as good as or possibly better
than the standard treatment. However, taking part in a clinical trial does not guarantee you better treatment and if you agree to enter the trial you will not be guaranteed the new treatment.

Entering a clinical trial

Entry into a clinical trial is optional. Your doctor and nurse will provide you with the information that you need to help make your decision. Before you enter the trial you will need to be clear about the following points:

• Your disease and its possible treatments
• Side effects of the proposed treatments
• What the trial involves

This will involve taking in a lot of information. If you feel that you need time to make your decision, you should take it. It is important that you have enough time to make your decision, and do not feel rushed.
In some clinical trials, extra tests and /or extra hospital visits are required. If there are any extra tests or hospital visits required, your doctor or nurse will explain these to you. You may also be asked to complete a questionnaire that asks questions about how you are
feeling and how you are coping with your treatment. This provides the researchers with valuable information about the treatment and its effects.

If you agree to enter the trial, you will be asked to sign a consent form. A consent form is signed in formal recognition that you understand what the trial involves and that you have chosen to enter it. Signing the form does not waive your rights.

If you enter the trial and you are unhappy, you can withdraw at any time. You do not have to provide an explanation. We will continue to provide you with the best possible treatment.

If you do not wish to enter the trial, you will be given the standard treatment, that is, the best-proven treatment we can offer.
Hopefully, you now have some idea of what a clinical trial is. If you have any questions or concerns, you may want to write them down. You can use your notes when you see your Research Nurse or Doctor.