Expanded access

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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^[1]. 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.

In December, 2006 the United States Food and Drug Administration proposed a new rule intended to improve access to investigational drugs for patients with serious or immediately life-threatening diseases or conditions, who lack other therapeutic options and who may benefit from such therapies^[2].

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The US National Cancer Institute (NCI) describes an expanded access trial as a way to provide an investigational therapy to a patient who is not eligible to receive that therapy in a clinical trial, but who has a serious or life-threatening illness for which other treatments are not available. Expanded access allows a patient to receive promising but not yet fully studied or approved cancer therapies when no other treatment option exists.^[3].