The Myth of Equipoise in Phase 1 Clinical Trials
Shamoo, Adil E.
Medscape Journal of Medicine 2008; 10(11): 254
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Amin, Sanjiv B.; McDermott, Michael P.; Shamoo, Adil E. (2008-07)The use of drugs for indications unapproved by the Food and Drug Administration (FDA), often called "off label use, "is widespread in children, including neonates. The widespread off-label use of drugs in neonates presents ...
Anderson, James A; Kimmelman, Jonathan (2010-03)Notwithstanding requirements for scientific/social value and risk/benefit proportionality in major research ethics policies, there are no widely accepted standards for these judgments in Phase 1 trials. This paper examines ...