I have been asked by my doctor to take part in a clinical trial. What does this mean?
When doctors are uncertain about whether one type of chemotherapy is better than another, or if a new treatment/drug mixture is likely to work or have side-effects, they try to answer this by involving patients in clinical trials. Most of the information that doctors have about how well different drugs work is obtained in this way. During a clinical trial detailed information is collected about each patient, drug side-effects and how well the treatment has worked. When this information is collected and compared from all the patients in your trial, it should become clear how good the treatment is. Without clinical trials it would be very difficult to know which cancer drugs work best.
How do I know that clinical trials are safe?
All clinical trials have to be passed by a committee of doctors and members of the public before they begin. Involvement in a clinical
trial is completely voluntary. If you decide that you want to stop being involved in a trial, then you simply have to tell your doctor. This will not affect your chances of future treatment if other options are available.
Where do clinical trials take place?
Trials take place in a variety of locations including cancer centres and district hospitals.
Are there different types of clinical trial?
Yes, there are three different types of clinical trial, which are detailed below.
A Phase I trial of a new drug, or mixture of drugs, is available if your cancer has returned despite having previous treatment, or there is no effective standard treatment available. If a new drug has been shown to work well in laboratory experiments and animal tests, it is important to know whether it also works well for humans, without causing too many side-effects. This usually involves weekly visits (sometimes more often) to the hospital to measure blood counts and assess side effects. You may like the close attention received during the visits but it can be disruptive to normal social and family activities. The dose of drug is increased with each new group of patients (usually three in each group). The main aim of the trial is to find the safest dose to deliver with a secondary aim of assessing the response to the drug.
Phase II
If results of a Phase I study show that a drug/treatment may be effective, without causing too many side-effects, then the next step is to a Phase II trial. This will examine how well a particular drug works for a certain type of cancer. The dose that you are given remains the same throughout the trial.
Phase III
If a treatment has successfully passed through Phase I and II a Phase III trial is performed. This compares two different forms of
treatment; usually the new treatment against the standard treatment. Phase III trials involve a larger number of patients than I and II, often involving hundreds of patients and taking many years to complete.
If you are interested in discussing clinical trials, then ask your cancer doctor for further information on what trials are available in your area.
Other sources for information about clinical trials can be found at