EXPANDED ACCESS

Expanded access refers to the inclusion of patients in a clinical trial for a new therapeutic treatment or chemical entity, where those patients would not satisfy the enrolment criteria for the scientific study in progress. This type of inclusion is made when it is clear that patients may benefit from the treatment, the therapy can be given safely outside the clinical trial setting, and no other effective therapy is available. Such a trial may be called an expanded access trial or a compassionate use trial and is an example of one manner in which individuals can gain access to investigational drugs. The guidelines for additional inclusion determined by the agency running the clinical trial is called an expanded access protocol. These trials are particularly important in therapeutic areas such as HIV/AIDS and Cancer.
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