Concurrent Plenary Sessions
Alexander Capron, LLB, MA (Hon).
University Professor; Scott H. Bice Chair in Healthcare Law, Policy and Ethics; Vice Dean, Faculty and Academic Affairs, Gould School of Law; Professor of Medicine and Law, Keck School of Medicine; Co-Director, Pacific Center for Health Policy and Ethics
University of Southern California
Clinical trials of new interventions are often seen as a “last hope” for patients with life-threatening conditions for which no curative therapy yet exists. Some trials, such as those involving “precision medicine” (i.e., interventions targeted to an individual’s genome), generate an especially high level of public and professional expectation. Should investigators and IRBs be concerned about the ability of patients to give informed and voluntary consent when invited to enroll in such clinical trials? Does the “personalized” nature of the interventions being investigated add to the sense they will be therapeutic for participants, even in Phase I or II trials? How should the choice to enter a trial be understood, both in terms of the potential benefits of the trial and the costs of other interventions, including palliative care, which may be forgone? What can physician-investigators do to frame the alternatives in a way that preserves hope while downplaying the hype?