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Adverse EventsRace, Inequality, and the Testing of New Pharmaceuticals$
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Jill A. Fisher

Print publication date: 2020

Print ISBN-13: 9781479877997

Published to NYU Press Scholarship Online: January 2021

DOI: 10.18574/nyu/9781479877997.001.0001

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PRINTED FROM NYU Press SCHOLARSHIP ONLINE (www.nyu.universitypressscholarship.com). (c) Copyright University of NYU Press Press, 2021. All Rights Reserved. An individual user may print out a PDF of a single chapter of a monograph in NYSO for personal use.date: 17 June 2021

A Laboratory for Human Animals

A Laboratory for Human Animals

Chapter:
(p.129) 5 A Laboratory for Human Animals
Source:
Adverse Events
Author(s):

Jill A. Fisher

Publisher:
NYU Press
DOI:10.18574/nyu/9781479877997.003.0006

The Phase I clinic can be seen as a type of laboratory for human animals. Chapter 5 further develops the concept of the healthy volunteer as a model organism, and it explores how standardization and control are imposed on healthy volunteers who are confined for studies. In Phase I clinics, what happens, and how often, to participants differs dramatically from later-phase clinical trials. Additionally, the strict inclusion-exclusion criteria for studies define “healthy” in terms of narrow physiological markers that volunteers must meet in order to participate. In the process, the healthy volunteer becomes a type of model organism that is maximally suited to Phase I research. The chapter also illustrates how research staff’s practices in selecting and managing healthy volunteers define who can enroll at their clinics and normalize those participants to the demands of Phase I trials.

Keywords:   Phase I trials, model organism, healthy volunteers, confinement, inclusion-exclusion criteria, pharmaceutical industry

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