EAP (Expanded Access Program)
What is it?
An Expanded Access Program, also called compassionate use, is a regulated pathway that lets a patient with a serious or life-threatening condition access an investigational, not-yet-approved drug outside of a clinical trial, when no comparable therapy is available. It requires regulatory sign-off and, usually, the manufacturer's agreement to supply the drug.
Crucially, going through an EAP doesn't switch off pharmacovigilance. Any adverse event experienced by an EAP patient still has to be captured, assessed, and reported through the same case processing pipeline as a trial subject or an approved-product patient.
Common Misconceptions
"Compassionate use sounds like a workaround. Isn't the safety oversight a lot looser than a real trial?"
It's still a regulated, permission-based pathway, not an off-the-books arrangement. Regulators review the request, and safety reporting obligations for the drug's manufacturer stay fully in force for every patient treated this way.
