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Experimental Therapies: Clinical Trials

Trying something new.  When companies are developing a new or “experimental” drug they have to run “clinical trials” to test how effective and safe the drug is for patients. The primary reasons to consider participating is to gain access to new research treatments before they are widely available and help others by contributing to medical research.

Not for everyone.  Drug trials are usually “double-blind”—meaning they require that some patients get the drug being tested and others get a “placebo” (a neutral, non-medication) and neither the doctors nor the drug company know who is getting what.  That means you won’t know either.  So you may go a year or more without any drug treatment.  If you are getting the medication, you won’t know much about potential problems it may cause—that’s why they are doing the study.  That being said, the FDA, drug companies, and researchers go out of their way to ensure that by the time a drug gets to trials, the odds are relatively low that their will be serious complications.  However, just a few years ago, after the then-new drug Tysabri entered the market, three patients in their trial experienced life-threatening complications during treatment and two died.  While the vast majority of patients tolerated the drug well and quiet a few saw significant improvements, the FDA removed the drug from the market for further investigation.  Ultimately, the FDA determined the benefits out-weighed the potential risks and allowed the company to re-introduce Tysabri on a strict protocol in an effort to prevent future problems.

If you are interested in participating in a clinical trial, please see the resources section for more information.