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Devil in the Details: Physician Duties and Expanded Access.

Holly Fernandez Lynch1

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The Journal of Law, Medicine & Ethics : a Journal of the American Society of Law, Medicine & Ethics
|May 25, 2023
PubMed
Summary

Physicians have a moral duty to inform patients about Expanded Access (EA) options. While the scope of this duty requires refinement, physicians should disclose EA pathways and support eligible patients in pursuing beneficial treatments.

Keywords:
AutonomyExpanded AccessInformed ConsentInvestigational DrugPhysician Duty

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Area of Science:

  • Medical Ethics
  • Patient Advocacy
  • Clinical Trials

Background:

  • Physicians may have a moral obligation to inform patients about Expanded Access (EA) opportunities.
  • Existing suggestions for this duty may be overly broad or insufficient for practical patient access.

Purpose of the Study:

  • To evaluate the scope and practical implications of a physician's moral duty regarding Expanded Access.
  • To define actionable expectations for physicians in disclosing and supporting patient access to EA.

Main Methods:

  • Conceptual analysis of ethical obligations related to Expanded Access.
  • Review of practical challenges and benefits associated with physician involvement in EA.

Main Results:

  • A broad moral duty for physicians to inform patients of all "relevant opportunities" for Expanded Access presents practical challenges.
  • A narrowly defined duty may not adequately promote patient access to potentially beneficial investigational treatments.

Conclusions:

  • Physicians should be knowledgeable about the Expanded Access pathway.
  • Disclosure of EA to eligible patients is recommended.
  • Physicians should support patients in pursuing EA options that are reasonably likely to offer benefit.