Allowing Innovative Stem Cell-Based Therapies Outside of Clinical Trials: Ethical and Policy Challenges
David Bourget (Western Ontario)
David Chalmers (ANU, NYU)
Rafael De Clercq
Ezio Di Nucci
Jack Alan Reynolds
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Journal of Law, Medicine & Ethics 38 (2):277-285 (2010)
This paper discusses exceptional circumstances under which patients outside of clinical trials are likely to receive innovative stem cell-based interventions. These circumstances involve: (1) stem cell interventions not initially amenable to a clinical trials approach; (2) expanded access to investigational stem cell products (“compassionate use”); and (3) off-label uses of FDA approved stem cell products. This paper proposes a new approach to regulating these exceptional cases
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References found in this work BETA
Rebecca Dresser & Joel Frader (2009). Off-Label Prescribing: A Call for Heightened Professional and Government Oversight. Journal of Law, Medicine & Ethics 37 (3):476-486.
Rebecca Dresser & Joel Frader (2009). Off-Label Prescribing: A Call for Heightened Professional and Government Oversight. Journal of Law, Medicine and Ethics 37 (3):476-486.
George J. Agich (2001). Ethics and Innovation in Medicine. Journal of Medical Ethics 27 (5):295-296.
Citations of this work BETA
John A. Robertson (2010). Embryo Stem Cell Research: Ten Years of Controversy. Journal of Law, Medicine & Ethics 38 (2):191-203.
Patrick L. Taylor (2010). Overseeing Innovative Therapy Without Mistaking It for Research: A Function-Based Model Based on Old Truths, New Capacities, and Lessons From Stem Cells. Journal of Law, Medicine & Ethics 38 (2):286-302.
John A. Robertson (2010). Introduction. Journal of Law, Medicine & Ethics 38 (2):175-190.
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