Clinical Trials for Parkinson's Disease
What Are the Disadvantages of Participating in a Clinical Trial?
- Because the drug or device being studied is new, all of the risks and side effects of the treatment are not known at the beginning of the clinical trial. There may be unknown side effects (as well as hoped-for benefits). Patients will be informed of any known side effects they could experience, as well as any side effects that occur or become known while they are participating in the trial.
- It is also important that you realize that if you participate in a clinical trial you may be given a placebo, which is a sugar pill containing no medicine. These tablets are used to determine if the real treatment is really working effectively. Trials are conducted in such a way that you will not be told if you're getting the real treatment or a "fake" treatment.
How Would my Care Be Different if I Participated in a Clinical Trial?
- You may receive more exams and tests than are usually given for your particular condition. The purpose of these tests is to follow your progress and collect study data. Of course, tests can carry certain benefits and risks or discomforts of their own. Although they can be inconvenient, these tests can assure extra observation.
- Depending on the type of clinical trial, you may be asked to stop or change the medication(s) you are currently taking. You may also be asked to change your diet or any activities that could affect the outcome of the trial.
- As mentioned above, you could get the placebo rather than the real medicine.
What Is Informed Consent?
Informed consent means that as a patient, you are given all available information so you can understand what is involved in a specific clinical trial. The doctors and nurses conducting the trial will explain the treatment to you, including its possible benefits and risks.
You will be given an informed consent form to read and consider carefully. Before signing, be sure you find out as much as possible about the clinical trial, including what risks you may face. Ask the researchers to explain parts of the form or the trial that are not clear. (See "Important Questions to Ask" below.)
You are free to decide whether or not you want to take part in the trial. If you decide to participate, you will sign the consent form. If you do not want to participate in the trial, you may refuse. If you choose not to participate in the trial, your care will not be affected in any way.
Your signature on the informed consent form does not bind you to the study. Even if you sign the form, you are free to leave the trial at any time to receive other available treatments.
The informed consent process is ongoing. After you agree to participate in a clinical trial, you will continue to receive any new information about your treatment that may affect your willingness to stay in the trial.