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A Laboratory for Human Animals

A Laboratory for Human Animals

(p.129) 5 A Laboratory for Human Animals
Adverse Events
Jill A. Fisher
NYU Press

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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