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DEAR MAYO CLINIC: Do I need to be in a clinical trial to get access to an investigational drug? If so, how do I find clinical trials that I may be able to participate in?
ANSWER: Investigational drugs are those allowed by the Food and Drug Administration (FDA) to be tested in clinical trials. Often, they are somewhere in the process of being studied for safety, effectiveness and intended use. By far, the most common way that people receive access to investigational drugs is by taking part in a clinical trial.
Your doctor may know about some clinical trials related to your specific circumstances. In addition, you or your doctor can search clinical trial databases at the National Institutes of Health (www.clinicaltrials.gov) or at the National Cancer Institute (www.cancer.gov/clinicaltrials/search).
Less commonly, people may qualify for access to an investigational drug outside of a clinical trial in what’s known as expanded access, or “compassionate use.” Expanded access is designed to allow people with serious diseases or conditions and life-threatening problems — and usually no further treatment options — access to promising investigational drugs that aren’t unreasonably risky. The drugs are not approved by the FDA and aren’t proven to be safe and effective.
However, there are a number of hurdles to clear. The drug manufacturer has to be willing and able to provide the drug. There may be numerous reasons why a drug company wouldn’t do this. If the drug is available, your doctor will need to submit an application to the FDA for review and approval. The protocol to use the investigational drug is reviewed by a review board to protect research participants. Your doctor may not agree to do this if the drug is unlikely to provide benefit, or if the drug can’t be properly administered or managed.
If you do obtain access to an investigational drug, an additional factor is cost. A drug company may or may not charge for the drug, but a health care provider is likely to charge for administering and monitoring of the drug. Insurance companies often don’t cover costs of an investigational drug. (adapted from Mayo Clinic Health Letter) — Christine Formea, Pharm.D., R.Ph.
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