The Ethical Challenges of Compassionate Use.

  title={The Ethical Challenges of Compassionate Use.},
  author={Arthur L. Caplan and Amrit Ray},
  volume={315 10},
Granting access to drugs, vaccines, biologics, and devices that have not yet been approved by governmental regulatory authorities is a growing challenge for physicians, public officials, patient advocacy groups, institutional review boards (IRBs), and patients.1 Although the issue of rapid access to investigational agents is not new, tracing back to the early days of the human immunodeficiency virus pandemic, the pace of requests has increased. This is attributable to many factors, including… CONTINUE READING