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The Risk-Escalation Model: A Principled Design Strategy for Early-Phase Trials

Should 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...

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Bibliographic Details
Published in:Kennedy Inst Ethics J
Main Authors: Hey, Spencer Phillips, Kimmelman, Jonathan
Format: Artigo
Language:Inglês
Published: 2014
Subjects:
Online Access:https://ncbi.nlm.nih.gov/pmc/articles/PMC4482673/
https://ncbi.nlm.nih.gov/pubmed/25109092
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