Little to lose and no other options: Ethical issues in efforts to facilitate expanded access to investigational drugs

When patients who are suffering from a serious or life-threatening illness have exhausted standard treatment options and cannot enroll in a clinical trial, they may be eligible for expanded access to unapproved, investigational drugs. These patients do not have the time to wait for marketing authorization of the drug, and may not meet inclusion criteria of available clinical trials (if there are any). Expanded access programs are intended for terminally or seriously ill patients for whom investigational drugs often represent one last chance at therapeutic benefit or survival.

Source: Health Policy - June 16, 2018 Category: Health Management Authors: Eline M. Bunnik, Nikkie Aarts, Suzanne van de Vathorst Source Type: research