Holly Fernandez Lynch, JD, MBe, Assistant Professor of Medical Ethics and Law at University of Pennsylvania will present on Expanded Access, a regulatory pathway that allows seriously ill patients to access investigational drugs outside clinical trials, but requires the engagement of several gatekeepers.
While much attention has focused on the role of FDA and companies, the role of clinicians has been underexplored: how do they decide whether and to whom to offer Expanded Access, what resources do they need, how do they navigate the pathway, and where might inequities occur? This lecture will present the results of qualitative interviews with oncologists practicing at large academic medical centers to shed light on these ethical challenges.
This Research Rounds will be presented via ZOOM. RSVP Today>>