What is a clinical study or clinical trial?

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.

To find out which treatment is best, some patients maybe asked to volunteer for one of the treatments and other patients to volunteer for the other treatment. Or, if more information is needed about a particular health problem, some patients may be asked to volunteer for regular evaluations over a period of time.

Why should I participate in this clinical study?

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.

What happens during a clinical study?

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.

The study team will then ask questions about your overall health, will give you a regular physical exam and will also schedule special tests. This information will be sent for evaluation to the statistical center at the Medstar Research Institute, in Maryland. You will have a regular schedule of study visits and telephone calls. It is very important that you come for all study visits in order for accurate information to be gathered.

Patients with stroke treated at other hospitals in the Washington DC area are also participating in this study. All of the participants will have the same interviews and tests. One hospital that cares for persons with stroke does not have enough patients to tell for sure if a particular treatment works so doctors from all over the city are working together and sending data from each of their hospitals (6 total) to the statistical center at the Medstar Research Institute. This way the information is based on the experience of many stroke experts with a large number of stroke patients.

What is informed consent?

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 process of telling you all about the study and getting your written permission to enroll you in the study is called informed consent. The process of informed consent continues throughout the study to keep participants up to date with any changes that may occur during the study. If there are any significant changes, you may be asked to sign an updated consent document. The informed consent document will describe every part of the study, any risks, and the steps that are taken to protect your privacy. However, an informed consent document is not a contract. You may quit the study at any time. The consent does not force you to do anything. It does let your doctor prove that he or she has followed all of the rules, has explained everything to you and has your permission to do the study.

Before a doctor or researcher can do a research study on patients, he or she must present the study to a committee at the hospital called an Institutional Review Board (IRB) or Human Studies Committee. This is a committee of scientists, as well as doctors, ministers, lawyers and people from the community. The researchers in charge of the project must work with the IRB to ensure that the study is safe, ethical, worthwhile, and will be conducted properly. One reason you must sign the informed consent document is so that the researchers can prove to the IRB committee that he or she has explained everything to you and that you understand what you are agreeing to do. The researchers must also prove that you were not forced to participate and that you freely volunteer for the study.

What are the benefits and risks of participating in a clinical study?

The specific risks and benefits of the study are outlined in the consent form. The main benefit of this study will be a better understanding of stroke. You may benefit by knowing that you have helped in this effort. You may also benefit by being helped by the results of some of the tests that will be done.

The main risk of the study is the time and effort needed to collect all of the study information. The study will require extra visits to the hospital and more time while the study information is collected.

How is the safety of study volunteers protected?

The study follows a plan that explains what we will do in the study. The plan was carefully designed by experienced neurologists, psychologists and other medical experts. After the plan is designed and before any changes are made it must be reviewed and approved by the IRB. The IRB acts as a supervising ethics committee and we must get permission from each IRB at each institution involved with the study. The IRB 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.

What should I consider before participating in a research study?

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?

Does a participant continue to work with a primary care physician or private neurologist?

Yes, your primary care physician or neurologist will remain the same. We will notify your regular doctor about your participation in the study.

Can I leave the clinical study after it has begun?

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. If you believe that you might move out of the study or leave the study, please let us know now. We may be able to make arrangements for you to stay in the study.

Who is the sponsor of this study?

The Triumph Over Stroke Program is sponsored by the National Institutes of Health, National Institute of Neurological Disorders and Stroke and Georgetown University.