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About Clinical Trials
A clinical trial is a complete investigation of medicines or medical devices to determine both their safety and efficacy before they are made available to the public.
A drug must go through many different phases of testing to prove it is safe and effective. This process is guided by regulations set forth by the Food and Drug Administration (FDA). All clinical trials are based on a set of rules called a protocol, which describes what types of people may participate in the trial, the schedule of tests, procedures and medications that are going to be used and the length of the study. Additionally, participants may decline to be a part of the trial or withdraw from the trial at any time. While in a clinical trial, participants are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of the treatment.
Are Clinical Research Studies Safe?
The government has strict guidelines and safeguards to protect people who choose to participate in clinical trials. Every clinical trial in the United States must be approved and monitored by an Institutional Review Board (IRB) to make sure the risks are as low as possible and are worth any potential benefits. Before participating in a trial, a person must agree to sign an Informed Consent form, which provides detailed information about the study, medications and procedures. Experienced physicians who have been thoroughly trained and designated as Principal Investigators also closely monitor study participants.
Why Should I Participate in a Clinical Trial?
By participating in a stroke clinical trial, you will:
- Gain access to new treatments that are not available to the public
- Obtain expert medical care at leading health care facilities during the trial
- Receive all medical visits related to the study free of charge. This includes physical examinations, doctor visits, study medications and laboratory tests.
- Take an active role in your own health care
- Help others by contributing to medical research
Research projects and clinical trials pertaining to post-stroke treatment are increasing each year. Stroke survivors and caregivers are encouraged to check the resource center page regularly for updates.
Other Helpful Websites
Two of the most comprehensive internet resources for rehabilitation research news are http://www.clinicaltrials.gov/ (from the NIH offices in Bethesda, MD) and http://kesslerfoundation.org/researchcenter/stroke/researchstudies (from the Kessler Foundation in West Orange, NJ). Not all of the trials listed at these sites pertain to post-stroke research, but many of them do. Visitors to the NIH site need to browse a few menus to find stroke information: select condition, then disease heading, then nervous system diseases, then cerebrovascular accident. The Kessler site, in addition to rehabilitation research, provides information on experimental techniques, explanations of processes for participating in research projects, and an on-line newsletter.
Visit the Clinical Trials Resource Center
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