Clinical Research & Clinical Trials

Compassionate use trials or expanded access trials

Expanded access refers to the administration of an investigational new medicine to patients for the diagnosis, observation, or treatment of a serious disease or condition outside of a clinical study. Contrarily, participants in clinical trials or studies—whether they are patients or healthy volunteers—are regarded as human subjects.

Expanded access may be necessary if all of the following hold true: Patient with a significant illness or condition, or whose illness or condition poses an imminent threat to their life. There is no alternative diagnosis method that is similar to or as effective