| What are clinical trials and should you participate in one?  Have you ever thought about participating in a clinical trial? Thanks to the dedication of thousands of individuals who have taken part in clinical trials funded by the National Heart, Lung, and Blood Institute (NHLBI), we have learned an enormous amount about the prevention and treatment of numerous diseases and conditions such as heart failure, childhood asthma, sleep apnea, sickle cell anemia, and heart disease.
What are clinical trials? Clinical trials are research studies that explore whether a medical strategy, treatment, behavioral intervention, diagnostic tool, or device is safe and effective for humans. These studies also may show which medical approaches work best for certain illnesses or groups of people. Clinical trials produce the best data available for health care decisionmaking.
Learn more about clinical trials What are the benefits and risks of participating in a clinical trial? Participating in a clinical trial can have many benefits. You may: - Gain access to new research treatments before they are widely available.
- Play an active role in your own health care and learn more about your condition.
- Obtain expert medical care at leading health care facilities during the trial.
- Help others by contributing to medical research.
Clinical trials may also have risks. For example: - The new treatment may not be effective for some individuals.
- There may be unpleasant, serious, or even life-threatening side effects from the new treatment.
- The study may require a lot of time for traveling to the study site, receiving treatments, or hospital stays.
What are the phases of clinical trials? Clinical trials of new medicines or medical devices are conducted in a series of steps, called phases. Each phase is designed to answer a separate research question. Trials of medical strategies, behavioral approaches, or diagnostic tools may not always include each of these phases. - Phase I: Researchers test an experimental drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
- Phase II: The drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
- Phase III: The drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
- Phase IV: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and on any side effects associated with long-term use.
What should you consider before participating in a clinical trial? You should feel free to ask members of the study team and other members of the health care team as many questions as needed for you to feel that you know as much as possible about the clinical trial. Questions that you may wish to discuss include: - What is the purpose of the study? How long will the study last?
- What kinds of tests and treatments are involved?
- Why do researchers believe the new treatment or approach being tested may be effective? Has it been tested before?
- How do the possible risks, side effects, and benefits in the study compare with my current treatment?
- How might this trial affect my daily life? Will I have to be in the hospital?
- Who will have access to my medical information while the study is going on? How will my confidentiality be protected?
- Who will pay for the study tests and treatments that I receive?
- Will I be reimbursed for other expenses, such as travel and child care?
- What type of long-term follow up care is part of this study?
- How will I know whether the study treatment is working? Will results of the trials or information about any safety concerns be provided to me?
- When the study ends, how will my treatment change?
Before you decide whether to enroll in a clinical trial, a doctor or nurse will talk with you about the study and go over the process of informed consent. Among the materials you will be asked to read is an informed consent form that presents key facts about the trial. If you agree to take part in the trial, you'll be asked to sign the form after you have time to read it and discuss it with members of the research team, as well as family members or other trusted advisors. The informed consent document is necessary for you to participate in the trial, but is not a binding contract. You have the right to withdraw from a study at any time, for any reason, without affecting your regular health care. Are there clinical trials for children?  Yes, there are numerous clinical trials for children. We need to study children because they can have conditions adults don’t have and because treatments may affect them differently depending on their stage of development. Research in children can be done safely, and has helped to save lives and improve health. For example, clinical trials on therapies for childhood cancers and congenital heart defects have improved survival and quality of life for children.
If you are thinking about enrolling your child in a study, you can learn more and get many of your questions answered at the NHLBI’s Web site, Children and Clinical Studies. How do I find ongoing clinical trials? To learn more about clinical trials, talk with your doctor. He or she may know about relevant studies in your area. The NHLBI supports clinical trials that are conducted at the National Institutes of Health (NIH) campus in Bethesda, Maryland, as well as trials that are conducted elsewhere by academic institutions and other organizations. Visit the NHLBI Clinical Trials Web site to learn more. In addition, ClinicalTrials.gov provides a searchable database of federally and privately supported clinical trials. This site lists more than 95,000 trials with locations in more than 170 countries. You can search for a trial by the name of the disease, the location of the study, the type of treatment, and the sponsoring institution. You may also wish to visit Research Match, a service funded by the NIH. The goal of this free and secure registry is to bring together people who are trying to find research studies and researchers who are looking for people to participate in their studies. You may either register yourself or someone else as their parent, guardian or caretaker.
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