A deviation from standard design? Clinical trials, research ethics committees, and the regulatory co-construction of organizational deviance

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Knowledge flows through informal contacts in industrial clusters: myth or reality?

Michael S Dahl, Christian Pedersen (2004)

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Scott A. Snook (2000)

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"Cytokine storm" in the phase I trial of monoclonal antibody TGN1412: better understanding the causes to improve preclinical testing of immunotherapeutics.

N. C. Edwards, Chris Bird, D. North … (2007)

The CD28-specific mAb TGN1412 rapidly caused a life-threatening "cytokine storm" in all six healthy volunteers in the Phase I clinical trial of this superagonist, signaling a failure of preclinical safety testing. We report novel in vitro procedures in which TGN1412, immobilized in various ways, is presented to human white blood cells in a manner that stimulates the striking release of cytokines and profound lymphocyte proliferation that occurred in vivo in humans. The novel procedures would have predicted the toxicity of this superagonist and are now being applied to emerging immunotherapeutics and to other therapeutics that have the potential to act upon the immune system. Data from these novel procedures, along with data from in vitro and in vivo studies in nonhuman primates, suggest that the dose of TGN1412 given to human volunteers was close to the maximum immunostimulatory dose and that TGN1412 is not a superagonist in nonhuman primates.

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Journal

Title: Social Studies of Science

Abbreviated Title: Soc Stud Sci

Publisher: SAGE Publications

ISSN (Print): 0306-3127

ISSN (Electronic): 1460-3659

Publication date Created: September 25 2013

Publication date (Print): October 21 2013

Volume: 44

Issue: 1

Pages: 59-81

Article

DOI: 10.1177/0306312713506141

SO-VID: f95c5880-d391-4638-add7-672f5351179b

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A deviation from standard design? Clinical trials, research ethics committees, and the regulatory co-construction of organizational deviance

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Abstract

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Regulatory T cell (Treg) therapy

Most cited references 47

Knowledge flows through informal contacts in industrial clusters: myth or reality?

Friendly Fire

"Cytokine storm" in the phase I trial of monoclonal antibody TGN1412: better understanding the causes to improve preclinical testing of immunotherapeutics.

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