The Ethical Challenges of Compassionate Use (U.S.) - daratumumab

JAMA Network - open access

 Wiki: daratumumab

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Viewpoint | February 11, 2016

¹Division of Medical Ethics, NYU Langone Medical Center, New York, New York
²Janssen Research & Development LLC, Titusville, New Jersey

  Requests for rapid access to agents still under investigation fall into 2 categories—requests for groups of persons with the same disease and requests by individuals. The former are often described as requests for expanded access, the latter as requests for compassionate use. Regulatory bodies in various countries have created various programs for providing greater access to requests from groups, including the creation of expanded-access programs and emergency use waivers for patients who do not qualify for clinical trials. Compassionate use requests have proven to be more difficult to resolve.