Kennedy Institute of Ethics Journal 24 (2):121-139 (2014)
AbstractShould first-in-human trials be designed to maximize the prospect of therapeutic benefit for volunteers, prioritize avoidance of unintended harms, or aim for some happy medium between the two? Perennial controversies surrounding initiation and design of early-phase trials hinge on how this question is resolved. In this paper, we build on the premise that the task of early-phase testing is to optimize various components of a potential therapy so that later, confirmatory trials have the maximal probability of informing drug development and clinical care. We then explore three strategies that investigators might use to manage trial risks while optimizing a therapy, using cell therapy for Amyotrophic Lateral Sclerosis (ALS) as an example. We argue that an iterative application of maximin strategies over successive cohorts and trials, which we call the “risk-escalation model,” establishes a moral principle that should guide decision-making in early-phase trials.
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References found in this work
First-in-Human Trial Participants: Not a Vulnerable Population, but Vulnerable Nonetheless.Rebecca Dresser - 2009 - Journal of Law, Medicine and Ethics 37 (1):38-50.
Beyond Access Vs. Protection in Trials of Innovative Therapies.Alex John London, Jonathan Kimmelman & Marina Elena Emborg - unknown
Citations of this work
How to Keep High-Risk Studies Ethical: Classifying Candidate Solutions.Nir Eyal - 2017 - Journal of Medical Ethics 43 (2):74-77.
Afterword: Returning to Philosophical Foundations in Research Ethics.Nir Eyal - 2017 - Journal of Medical Ethics 43 (2):132-133.
Can Risks Be Offset by the Prospect of Benefit in Trial Design?Hannah Grankvist - 2015 - American Journal of Bioethics Neuroscience 6 (1):61-62.
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