Clinical Research at The Neuro Center
What is clinical Research?
Clinical research involves testing an investigational drug or device in humans. Each clinical trial must use a protocol that has been written according to government regulations and that is also approved by the company sponsoring the study. An investigational drug may be:
- a drug that has not yet been approved for marketing (i.e., a drug that is not allowed to be sold)
- a drug that is currently on the market but that is being studied for a non-approved indication or is being studied in a new route of administration, strength, or formulation;
- a drug that is being sold on the market by one company but that is being considered for in-license or acquisition by another company;
a drug that contains known and established ingredients but has not yet been marketed by the company; - a drug that is currently on the market but is being studied in a population for which the drug has not yet been approved, such as in children or in elderly patients.
WHY SHOULD I PARTICIPATE IN A CLINICAL TRIAL?
People choose to take part in clinical trials for many reasons. Usually, they hope for benefits for themselves such as hope for a cure of disease, a longer time to live, an increased quality of life, or a way to decrease or eliminate pain. Some people choose to participate because of the financial compensation they receive. Others may want to contribute to a research effort that may help others.
People who participate in clinical trials are among the first to receive new research treatments before they become widely available. Sometimes these people have the first chance to benefit from a cutting-edge treatment. However, there is no way to know whether an investigational treatment will be effective for a patient. (Even standard treatments, although effective in many patients, do not guarantee benefits for everyone.) Some people in a study may not receive the active treatment and instead will receive a placebo (i.e., a sugar pill). Although all patients in clinical trials are carefully monitored both during and after conclusion of the trial, there are always known and unknown risks associated with new treatments. Patients should decide whether or not to participate in a study only after they understand both the potential risks and benefits.
People who participate in clinical trials are among the first to receive new research treatments before they become widely available. Sometimes these people have the first chance to benefit from a cutting-edge treatment. However, there is no way to know whether an investigational treatment will be effective for a patient. (Even standard treatments, although effective in many patients, do not guarantee benefits for everyone.) Some people in a study may not receive the active treatment and instead will receive a placebo (i.e., a sugar pill). Although all patients in clinical trials are carefully monitored both during and after conclusion of the trial, there are always known and unknown risks associated with new treatments. Patients should decide whether or not to participate in a study only after they understand both the potential risks and benefits.
Who can participate?
All clinical trials have criteria that determine who is allowed to participate. You cannot participate in a study if you don’t meet all of the study criteria. These criteria include such factors as age, type of disease, medical history, and current medical condition. Some studies seek volunteers with specific medical conditions and others seek healthy volunteers. It is important to note that these study entry criteria are not used to reject people personally. Instead, the criteria are used to identify appropriate participants and keep them safe. The criteria help ensure that researchers will be able to answer the questions they plan to study.
WHAT SHOULD I KNOW BEFORE PARTICIPATING IN A RESEARCH STUDY?
You should know as much as possible about the research study before you participate. It is important that you feel very comfortable asking questions and that the staff answers them in a way you can understand. When preparing for a meeting with the study coordinator or doctor you should plan ahead and write down the questions you want to ask. Review the study website to help you prepare questions to ask. You might ask a friend or relative to come with you for support and to hear the responses to your questions. You may want to ask the following questions when deciding whether to participate in a clinical trial:
- What questions should I ask?
- Why is this research being done?
- What is the purpose of the study?
- Who is sponsoring the study?
- Who has reviewed and approved this study?
- Why does the research team think the treatment, drug, or medical device will work?
- What kinds of therapies, procedures, and/or tests will I have during the trial?
- Will they hurt? If so, for how long?
- How will the tests in the study compare to tests I would have outside the study?
- How long will the study last?
- How often will I have to go to the study site?
- Will I be able to take my regular medications during the trial?
- What medications, procedures, or treatments must I avoid while in the study?
- What are my responsibilities during the study?
- Will I have to be in the hospital during the study?
- Will the study researchers work with my doctor while I am in the study?
- Can anyone find out that I am participating in a study?
- Can I talk to other people in the study?
- Will I be able to find out the results of the trial?
- Questions about risks and benefits include:
- How do the possible risks and benefits of the study compare with approved treatments for me?
- What are the possible immediate and long-term side effects?
- Will I have to pay anything to participate in the study?
- What are the charges likely to be?
- Is my insurance likely to cover those expenses?
WILL I GET PAID FOR PARTICIPATING IN A RESEARCH STUDY?
You will usually be paid for your time and travel while participating in a clinical study. Surgery, medical exams, and medical procedures may also be performed at no cost to you depending on the type of study. If a study requires you to stay at a research facility for any length of time, you may also receive meals or snacks.
CAN I STOP PARTICIPATING IN A STUDY ONCE I HAVE STARTED?
Yes, you can leave a clinical trial at any time. This is called “withdrawing your consent.” If you plan to stop participating in a study, inform the Study Coordinator or Principal Investigator that you would like to withdraw your consent. You should also inform the Study Coordinator or Principal Investigator of your reason for withdrawing.
What Happens during a study?
The study procedures and process will vary depending on the type of clinical trial you participate in. Before you begin a study, the process and all procedures for that study will be explained to you. Throughout the study, the Study Coordinator and the Principal Investigator will assist you and can answer any questions you have. They will check your health at the beginning of the trial, give you specific instructions for participating in the trial, monitor you carefully during the trial, and stay in touch with you after the study.
Some clinical trials involve more tests and doctor visits than you would normally have for your illness or condition. Your participation will be most successful if you carefully follow all instructions you are given and stay in contact with the research staff.
Some clinical trials involve more tests and doctor visits than you would normally have for your illness or condition. Your participation will be most successful if you carefully follow all instructions you are given and stay in contact with the research staff.
What are the risks of participating?
Most all investigative treatments can cause side effects and other health risks. Side effects and health risks vary from patient to patient. The number of side effects, if any, you experience will depend on the type of treatment being studied and your medical condition. Because clinical trials evaluate new medical treatments, the risks of the treatments are not always known ahead of time. However, in every study several safeguards are put in place to protect the safety of the participants. Before you agree to participate in a study, it is important that you know what side effects may occur and, as much as possible, what unknown side effects or risks may occur. This information will be covered thoroughly during the informed consent process before you enroll in the study.