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In Clinical Trials, What Is Compassionate Drug Use?

Unfortunately, I didn't qualify for a clinical trial of a new drug that could treat my type of cancer. However, my doctor said that perhaps I could still try the drug through a "compassionate use" program. I'm baffled by this term. As far as clinical trials go, what is compassionate drug use?
 

Answer

Compassionate drug use is when an unapproved drug that is currently being studied is given to a person who is not participating in a clinical trial. Normally, unapproved drugs being studied (called "investigational" drugs) can only be accessed through clinical trials. However, there are several reasons why a person might not be able to be in a trial. They might not meet the strict criteria for who can be in it (for instance, they might be too young or too old), or they might be too far away from a clinical trial. In such cases, the drug manufacturer (with the approval of the Food and Drug Administration, of course) may provide someone not in a trial with the study medication.
 
It's not easy to get a drug through compassionate use. There are lots of legal hoops for everybody to jump through, and there is no way to force a drug company to provide you with a drug -- they may not want to give it to you for medical, legal, or financial reasons. However, it can be a viable option for some people. Your doctor can provide you with more information about compassionate use options for your unique situation.
 
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