Also know as expanded access trials, compassionate use trials allow participants with life-threatening or serious conditions who do not qualify for conventional clinical trials access to experimental treatments. These trials are typically used when no other treatment options are available.
Compassionate use clinical research trials in United States allow patients with serious or immediately life-threatening diseases or conditions to gain access to investigational medical products such as drugs, biologics, or medical devices outside of clinical trials when there are no comparable or satisfactory alternative therapies available.
Patients must have a serious or immediately life-threatening disease with no comparable or satisfactory alternative treatments.
Your doctor must submit a request to the FDA, explaining why the patient needs an investigational drug and why there are no other suitable options. The FDA will review the request and may grant expanded access if it’s determined to be appropriate. If approved, the doctor can prescribe the investigational drug.
There are risks related to untested and unapproved drugs. The FDA may place conditions on expanded access, such as requiring a patient to be enrolled in a registry to monitor their progress. Not all drug manufacturers participate in expanded access programs.
Compassionate use is not a clinical trial. It’s designed to provide treatment to individual patients, not to collect data for research purposes. The FDA has the final say on whether expanded access is granted. While compassionate use can offer hope to patients with limited options, it's important to weigh the potential risks and benefits carefully.
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