Opening the Regulatory Black Box of Clinical Cancer Research: Transnational Expertise Networks and “Disruptive” Technologies |
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| Authors: | Alberto Cambrosio Pascale Bourret Peter Keating Nicole Nelson |
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| Institution: | 1.Department of Social Studies of Medicine,McGill University,Montreal,Canada;2.Aix Marseille Univ, INSERM, IRD, SESSTIM,Marseille,France;3.Department of History,Université du Québec à Montréal,Montreal,Canada;4.Department of History,University of Wisconsin-Madison,Madison,USA |
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| Abstract: | Building on previous work on “regulatory objectivity,” the paper examines recent translational research and cancer genomics to explore the bundle of scientific and regulatory activities that generate and manage the platforms at the core of clinical trials, the “gold standard” of clinical research and evidence-based medicine. In particular, the paper explores the activities of a chain of mediators within a seamless regulatory web characterized by the interaction of endogenous and hybrid regulatory activities that are neither hierarchical nor linear. We contend that a full understanding of the dynamics of regulation in the biomedical domain ought to consider this chain of mediations; that their analysis necessitates understanding the content of the practices they regulate; and that in addition to examining the interactions between different regulatory modalities, we need to pay attention to their development insofar as regulation, far from being mere routine, leads to the emergence of novelty by coproducing the entities it regulates. These activities include not only setting out the conditions that must be respected in order to produce reliable test results, but also the conditions that define the relations (within a clinical context) between the different components of diagnosis as well as the consequences of such relations on clinical judgment. This is why we cannot treat organizational practices as distinct from the content of bio-clinical activities. |
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