What does randomisation mean?
Most Phase 3 trials are randomised. This means that the people taking part in the trial are put into one of the two or more groups in order to avoid bias. The researchers do not have any say in who goes in which group. It is usually decided by a computer. This helps make sure that there are similar patients in each group, and that any differences in results are due to the treatment and not differences in age, gender or stage of cancer, for example. Where there are two groups, one group is randomly selected to take the new treatment or drug. The other group is given the current standard treatment or drug. This group is known as the control group.
What is a placebo?
If there is no known standard treatment then a Phase 3 trial may compare a new treatment with no treatment at all. This is known as a dummy treatment or a placebo. The group assigned to having no treatment would take the placebo. The placebo may be a pill, injection or ointment that has most of the characteristics of the real medication but it contains none of the active ingredients and it will not be of any medical value to the person taking it. Using a placebo is quite rare in cancer clinical trials because most people with cancer will need some kind of treatment. It would be unethical to withhold treatment in favour of a dummy pill and it is more common to give a placebo with a standard treatment. Medical teams must advise participants in advance if the trial involves a placebo.
Should I take part in a clinical trial?
This can be a very difficult question to answer and only you can decide. Not everyone is able to take part in a trial. Each trial will be looking for men who fit a very specific set of criteria. For example, your PSA level may need to be within a certain range, or your cancer may need to be at a particular stage. Other factors may also be taken into account such as how fit you are and if the trial is taking place in a centre you can easily get to. The databases listed at the end of this fact sheet include the criteria for current trials. Your doctor can also give you more information about your suitability for any trial. Before making any decisions, it is important to find out as much as you can about a trial including its potential advantages and disadvantages. Each trial is different but generally taking part in a trial means that you may: • Help to improve future cancer treatments for others. • Access newer and perhaps more effective treatments otherwise unavailable outside the trial. • Have more regular check-ups and tests than usual. Some people find this very reassuring. If you take part in clinical trials you may also have a better health outcome than people with a similar stage and type of cancer who do not participate. This is because taking part in the trial you will be: • Very closely monitored. • Receive care provided by some of the best health professionals in the field of cancer research. • Receive on-going care once the trial is over. A recurrence may, therefore, be picked up sooner. • Feel that you are taking a more active role in your treatment and recovery. This often helps people feel more in control and able to cope with their situation.
As with all treatments, there are also risks involved with taking part in a trial. These include: • Possible inconvenience of more frequent testing. Some people find this makes them more anxious about their cancer. • You may have unexpected side effects from the treatment especially if it is an early phase trial (Phase 1 or 2). • If the trial is randomised you will not get a choice about which treatment you have. You may not even know which treatment you are getting. This is called a blind trial. • As with most treatments, there is the risk that the new treatment may not help you, even if it helps others. You have to decide whether the risks outweigh the benefits. It is important to have a realistic view of what going on a specific trial means for you. Some questions to ask your doctor are listed further on in this fact sheet. The answers may help you make a decision about whether or not taking part in a particular clinical trial is right for you.
What does taking part in a trial involve?
If you decide to take part in a trial, the research team will give you the full details of what it will involve. All trials have guidelines for who can and cannot take part. Doctors call these ‘eligibility criteria.’ This is to make sure that trials compare similar groups of people and that they are safe. There will be differences between trials and some involve a lot more paperwork, tests and trips to the hospital than others. All trials will involve signing a consent form to say that you understand what taking part means and that you agree to take part in the trial. No one can enter a trial without signing this form. The medical team will give you information about the trial and will have time to answer questions before you agree to sign the consent form. The important factors to consider when deciding whether to sign this form include: • Do you feel comfortable with the frequency and types of tests (blood tests, scans etc) that need to be done during the course of the trial? • Can you get to the hospital for the tests and treatment? Many people having cancer treatment find travelling long distances very tiring. • Do you clearly understand the possible side effects and risks of having the treatment?
What are my rights when taking part in a clinical trial?
You can leave a trial at any stage you want without giving a reason. Leaving a trial does not mean that you cannot have treatment for your cancer, nor does it mean that your medical team will treat you differently. You will still be given the current standard treatment for your stage of cancer. Like all other medical treatments, the information about you and the clinical trial itself is confidential. Only the medical team and the staff involved in conducting the trial will have access to this information. This remains private unless you give your permission for information to be disclosed. Records of your progress in the trial will be identified by a code number, not your name.
What does randomisation mean?