Risks and Benefits of Clinical Trials
Clinical trials are carefully designed to minimize the risks and maximize the benefits to all who take part, whatever treatment they receive. Some trials will have very little risk involved. However, the risks of a trial may be greater when less is known about the treatment being evaluated. Before any drugs are given to people, they will have been developed in a laboratory and used with animals to check for safety.
The treatment tested in any trial may cause side effects that doctors cannot predict and that you may not expect. These may be unpleasant and, rarely, can be life-threatening. You should be told everything known about any possible risks and side effects and why the trial is necessary so that you can make an informed choice about whether to take part.
If you do participate in a trial, you will be monitored regularly during and after the study. You will be given regular tests, and you may be asked some extra questions about how you are feeling. You may also be asked to fill out questionnaires or keep a diary. Sometimes this means going to your hospital or general practitioner more often than you would normally, so bear this in mind before you agree to participate. Ask how many extra visits will be needed and consider how convenient this will be for you. Often there will be money available to help with any extra costs you have.
The benefit to you of this extra attention is that any changes in your health, whether or not they are related to the trial treatment, are frequently picked up and acted upon earlier than if you were not in a trial. However, some people find that the extra attention makes them worry more about their condition and prevents them from going about their lives.
It is important to remember that not participants receive the trial treatment. A clinical trial needs to compare a new treatment with the standard treatment already in use if there is one. Some people in a trial will therefore receive the standard treatment but, until the results of the trial are analyzed, no one will know which treatment is better. “New” does not always mean “better”, and you may not be worse off if you do not receive a new treatment.
People who take part in trials often feel that they are taking an active part in their health care. They may be helping themselves and other by helping to identify the best treatments.