It depends. One purpose of a clinical study is to measure rates of side effects. If a drug is very new, there may be serious side effects – including possibly fatal side effects – that nobody knows about yet.
Also, new treatments may not work very well. As a general rule, the more people that have taken the treatment being studied, the more likely that researchers will understand and be able to explain the potential risks of the study.
Before you are enrolled in a clinical trial, all of the known risks and benefits will be explained to you. This process is called Informed Consent. You will also be given a form to sign that explains all of this information. The Informed Consent form explains the rules of the trial in plain, everyday language. It is important to be sure that you understand everything in the Informed consent form, and that you keep a copy for yourself.
If you don't understand something, ask questions. Don't feel like you are asking too many questions, or taking up too much time. Clinical trials need participants like you, and you have a right to fully understand the commitment you are making. It will probably be helpful to write down the answers to your questions, so that you have the information later on.
However, it is important to know that some questions can't be answered. For instance, the side effects of a new treatment may not be known. In that case, the person explaining the trial to you may tell you what might happen, but may add that they do not know for sure.
Each trial has a set of rules. These rules are called the protocol. The protocol includes rules about how often you will have to go to the trial site, and what tests will be done. These rules should be explained in the informed consent form. Again, it is important that you understand the requirements, and that you are pretty sure you will be able to follow them.
Even after you have signed an informed consent form, you can withdraw from the study at anytime, and for any reason.
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