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Medicines or medical devices must go through a complete investigation and many different phases of testing (clinical trials) to prove that they are safe and effective. Get more information on what they are, if you can participate, the research behind them, and how to enroll in stroke clinical trials.
What are Clinical Trials?
Pseudobulbar affect is a neurologic condition that can occur when certain neurologic diseases or brain injuries damage the areas of the brain that control normal expression of emotion. PRISM II is a real-world registry to study the safety and effectiveness of a treatment for pseudobulbar affect (PBA) in post-stroke, dementia and traumatic brain injury (TBI) patients. Learn more.
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 U.S. 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:
How Can I Enroll in a Stroke Clinical Trial?
To locate clinical trials near you and find out more about clinical trials visit ClinicalTrials.gov, a service of the U.S. National Institutes of Health. ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world.
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.
The content of this webpage does not imply National Stroke Association's endorsement of any product, treatment, service or entity. National Stroke Association strongly recommends that you consult with a healthcare professional about diagnosis and treatment before participating in a clinical trial. National Stroke Association has no affiliation with any specific clinical trials.
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