Also, new treatments may not work very well. This is important for people with viral hepatitis, because a weaker or less potent drug or regimen may cause your virus to develop resistance to a certain med, or whole family of meds. Some trials have “stopping rules” to lower the risk of resistance, so you may have to stop taking an experimental drug because it is not working for you.
As a general rule, the more people who have taken the treatment being studied, and the further along in development it is, the more likely that researchers will understand and be able to explain the potential risks of the study.
Some studies today involve experiments that may not offer a personal benefit, but they are critical to research exploring curative treatment approaches. If you decide to enroll in these trials, make sure you understand fully what you are getting into.
Before you enroll in any clinical trial, all of the known risks, benefits, rights and responsibilities should be explained to you. This is known as informed consent. During the informed consent process, you should receive a detailed written explanation of the rules of the clinical trial. It should be written in plain, everyday language and should be translated for people who do not understand English. It is important to be sure that you understand everything in the informed consent document, and that you keep a copy for yourself. When you are ready, you will be asked to sign the document. You will receive a copy that has been signed by you and the person in charge of the study—the principal investigator (PI)—at the clinical trial site.
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 might 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—after all, clinical trials are conducted to answer important questions. 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 the researchers do not know for sure.
Remember, less is known about a drug being studied in Phase I or II.
Each trial has a set of rules. These rules are called the protocol—the blueprint of the study. The protocol includes rules about how often you will need to visit the study site, along with the tests that will be done, and if and when you will be given your test results. These rules should also be explained in the consent form. Again, it is important that you understand the protocol and that you are pretty sure you will be able to follow it.
If there are any changes to the protocol, a new informed consent may be given to you to read and sign. Again, make sure you understand any changes that are being made along the way before you sign.
Know that the informed consent is not a binding contract—you have the right to withdraw from the study at any time, and for any reason.