Clinical trials

Clinical trials are research studies designed to answer certain questions about potential new treatments for brain injury. Certain people who meet specific criteria are eligible to participate in these research studies, often gaining access to the newest, most cutting-edge treatments.

But are clinical trials safe? First of all, you should know that before a clinical trial takes place, there is a process it must go through. For starters, an ethics board must review the clinical trial to determine whether it should be allowed to go forward. This board, called the Institutional Review board, comprises independent doctors, scientists, statisticians, and community advocates who have all come together to determine that the trial is ethical. If the clinical trial is given the “thumbs-up” by the ethics board, people who volunteer to participate and meet the specific criteria must be made aware of both the potential benefits and risks of participation. In the end, it is always up to the survivor to carefully weigh those risks and benefits to determine whether they are good candidates for the trial. While some studies do provide remuneration to participants, this should never be a consideration when it comes to whether or not to participate. Here are a few questions you should always ask before deciding whether or not to participate in a clinical trial:

• Who are the researchers?
• Why is the research being done, and what do the researchers hope to accomplish?
• What will be done during the trial?
• How long will the trial last?
• What are the potential side effects of the treatment?
• What are the risks and benefits of the treatment?

What are some of the pros and cons of clinical research trials? Well, clinical research trials often study the most scientifically advanced, cutting-edge treatments available. That means if you meet the study’s eligibility guidelines—if you meet the type of injury, age, and medical history requirements—you’ll have access to treatment that hasn’t yet hit the mainstream, and may experience an outcome that otherwise might not be available. That being said, there are no guarantees when it comes to clinical trials. You may not experience any of the potential benefits at all, and may even experience negative side effects. It’s important to know that as a participant in a clinical trial, you are not obligated to finish the trial if it isn’t working for you. You can leave at any time.

Where do you find clinical trials? One of the best places to find clinical research trials is by searching on the web. Information about clinical research trials related to brain injury can be found on the following websites:

www.centerwatch.com. CenterWatch lists clinical research trials, and also allows visitors to be notified by email of clinical trials that might fit their profile.

www.clinicaltrials.gov. Provided by the National Institutes of Health, the National Library of Medicine, and the Federal Drug Administration, this site lists a large amount of clinical trial both in the United States and in 70 additional countries.

www.cc.nih.gov. This website for the Warren Grant Magnuson Clinical Center lists trials funded by the National Institute of Health.

Finally, there are two great pieces of literature we recommend for anyone who is interested in learning more about clinical research trials. The first is called The Guide to Clinical Research, and is published by the Warren Grant Magnuson Clinical Center. You can find this pamphlet through the National Institute of Health. The second is called The Bill of Rights for Clinical Center Patients, and is available through the National Hospital Association.

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