- What is a clinical study or clinical trial?
- Why should I participate in this clinical study?
- What happens during a clinical study?
- What is informed consent?
- What are the benefits and risks of participating in a clinical study?
- How is the safety of study volunteers protected?
- What should I consider before participating in a research study?
- Does a participant continue to work with a primary care physician or private neurologist?
- Can I leave the clinical study after it has begun?
The purpose of a clinical study or clinical trial is to determine the best treatment for a particular disease or to understand more about what causes the disease. Clinical studies are done when:
- There is more than one way to treat a patient for a particular problem.
- If the current treatments work better for some groups of patients than they do in other groups.
- If the best treatment for a particular problem is not clear.
The most important reason for persons with stroke to participate is to help us develop better ways to diagnose and treat stroke. Better treatments cannot be developed unless persons with stroke participate in clinical studies. Stroke patients who volunteer for this study will be closely observed by their stroke neurologist, nurses and health educators. There may not be direct benefit to you from taking part in this clinical study, the main reason to volunteer is to help us learn how to provide better care for all persons with stroke.
The first step is to make sure you understand everything that will happen to you and the things you will be asked to do as part of the study. You will have to sign a paper that states you understand this. This is called informed consent and is explained in more detail below.
Different studies have different activities. You can learn more about specific ongoing clinical studies here.
Before someone can participate in a clinical study, he or she must sign a paper giving permission for the doctors or researchers to do the study and stating they understand everything that will happen. Patients who participate in a clinical study must understand:
- What they are agreeing to do
- All of the possible risks of being in the study
- How much time it will take to be in the study
The specific risks and benefits of the study are outlined in the informed consent form specific to the study.
Studies follow a plan that explains what will occur in the study. The Institutional Review Board (IRB) at each institution acts as a supervising ethics committee ensures both the medical safety and protection of the participants involved in the study.
A clinical study also has to adhere to local and federal laws protecting participant safety. These laws include the federal patient privacy act (HIPPA). In addition the Federal Drug Administration can audit the files of a study to ensure that they are correctly following study procedures.
For any research study that someone asks you to participate in you should know as much as possible about the study and feel comfortable asking the research staff questions about the study. The following questions might be helpful for you to discuss with the neurologist, research coordinator, or nurse. Some of the answers to these questions are found in the informed consent document.
- What is the purpose of the study?
- Who is going to be in the study?
- Why are the researchers doing the study?
- If there are treatments, have they been tested before?
- What kind of tests and treatments are involved?
- How do the possible risks, side effects, and benefits in the study compare with my current treatment?
- How might this study affect my daily life?
- How long will the study last?
- What type of long term follow-up is involved in the study?
- Will results of the study be provided to me?
- Who will be in charge of my care?
Yes, your primary care physician or neurologist will remain the same.
Yes, you may leave the clinical study at any time. When you leave the study, you should let the clinical team know why you would like to stop the study.