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Access to Investigational Drugs Outside of Clinical Trials: What's Fair?
Session Chair(s)
Alison Bateman-House, PhD, MA, MPH
Assistant Professor, Division of Medical Ethics, Dept of Population Health
NYU Grossman School of Medicine, United States
Requests for investigational drugs are increasing, posing ethical, regulatory, and logistical challenges for companies. After discussing a fictional case, participants will understand these challenges and be better prepared to address them.
Learning Objective : Discuss ethical, legal, and practical concerns surrounding patient requests for access to investigational drugs outside of clinical trials (preapproval access); Apply this knowledge to a fictitious case study; Analyze the pros and cons of different possible responses in real world scenarios.
Speaker(s)
Facilitator
Beverly L Harrison
Janssen Pharmaceutical Companies of Johnson & Johnson, United States
Head, Patient Support
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