Opening the Regulatory Black Box of Clinical Cancer Research: Transnational Expertise Networks and “Disruptive” Technologies

Cambrosio, Alberto; Bourret, Pascale; Keating, Peter; Nelson, Nicole

doi:10.1007/s11024-017-9324-2

Cited by 17 publications

(20 citation statements)

References 62 publications

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“…The MoH representatives sought to make their guidelines “evidence based” by relying on EBM as well as by producing knowledge collectively, by seeking consensus among both medical experts and policy makers through the establishment of committees and consultations. That is, the regulators aspired to both “regulatory objectivity” (Cambrosio et al 2006, 2017) and “administrative objectivity” (Lynch 2008), hoping that “mechanical objectivity” (Daston and Galison 1992) would be attainable in the future. As research on regulatory objectivity has demonstrated (Cambrosio et al 2017), regulators essentially coproduced the entity termed “medical cannabis,” in the sense that MC did not exist prior to the establishment of the rules that regulate its production and use.…”

Section: Discussionmentioning

confidence: 99%

“…“Regulatory objectivity is based on systematic recourse to the collective production of evidence. It consistently results in the production of conventions most often arrived at through concerted programs of action” (Cambrosio et al 2017, 164). In contradistinction to the context-free mechanical objectivity, regulatory objectivity includes unprecedented levels of reflexivity, relying on the deliberate and conscious formation of an internal consensus about how to proceed “objectively”—a consensus that is often pragmatic and situation dependent (Cambrosio et al 2009).…”

Section: Background and Conceptual Frameworkmentioning

confidence: 99%

“…In contradistinction to the context-free mechanical objectivity, regulatory objectivity includes unprecedented levels of reflexivity, relying on the deliberate and conscious formation of an internal consensus about how to proceed “objectively”—a consensus that is often pragmatic and situation dependent (Cambrosio et al 2009). Multiple bioclinical entities, the authors argue, including clinical trials—which are the “gold standard” of EBM—are coproduced by regulation through consensus panels in which experts often strive to reach practical solutions (Cambrosio et al 2017).…”

Section: Background and Conceptual Frameworkmentioning

confidence: 99%

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“Medical Cannabis” as a Contested Medicine: Fighting Over Epistemology and Morality

Zarhin

Negev

Vulfsons

et al. 2019

Science, Technology, & Human Values

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Few empirical studies have explored how different types of knowledge are associated with diverse objectivities and moral economies. Here, we examine these associations through an empirical investigation of the public policy debate in Israel around medical cannabis (MC), which may be termed a contested medicine because its therapeutic effects, while subjectively felt by users, are not generally recognized by the medical profession. Our findings indicate that beneath the MC debate lie deep-seated issues of epistemology, which are entwined with questions of ethics and morality. Whereas some stakeholder groups viewed evidence-based medicine and mechanical objectivity as the only valid knowledge base, others called for recognition of a particular experience-based knowledge, championing regulatory, administrative, or strong objectivity. Stakeholders’ interpretations of what should be considered as ethical courses of (in)action corresponded to their epistemological views, with most criticizing the regulators for relying on regulatory subjectivity instead of objectivity. Our in-depth mapping of this arena allowed us not only to shed light on the emergence of the new entity called “medical cannabis” but also to reexamine the link between epistemology, ethics, and action and to elucidate how heterogeneous groups view the validity and objectivity of knowledge and the interface between medicine, science, and policy.

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Section: Discussionmentioning

confidence: 99%

Section: Background and Conceptual Frameworkmentioning

confidence: 99%

Section: Background and Conceptual Frameworkmentioning

confidence: 99%

See 1 more Smart Citation

“Medical Cannabis” as a Contested Medicine: Fighting Over Epistemology and Morality

Zarhin

Negev

Vulfsons

et al. 2019

Science, Technology, & Human Values

View full text Add to dashboard Cite

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“…Recursively, the standard-making process of technologies often ‘loops back’ on their functional and organizational configuration (Cambrosio et al 2014 , 2017 )), as it re-configures the criteria at the core of institutionalized regulatory frameworks, and questions what counts as legitimate ‘evidence’ for regulatory purposes, as well as how agencies conceive of their organizational cultures and functions. In line with this, Pickersgill ( 2019 ) refers to practices of ‘performative nominalism’, or the co-emergence of actors of innovative new fields “talking [these innovations] into existence” (pp.…”

Section: Social Studies Of Standard-makingmentioning

confidence: 99%

The FDA’s standard-making process for medical digital health technologies: co-producing technological and organizational innovation

2021

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As digital health technologies (DHT) have been embraced as a ‘panacea’ for health care systems, they have evolved from a buzzword into a high priority objective for health policy across the globe. In the realm of quality and safety standards for medical devices, the US Food and Drug Administration (FDA) has been a frontrunner in adapting its regulatory framework to DHT. However, despite the utmost relevance of quality and safety standards and their role for sustaining the innovation pathway of DHT, their actual making has not yet been subjected to in-depth social-science scrutiny. Drawing on the conceptual repertoires of Science and Technology Studies (STS), this article investigates how digital health evolved from a buzzword into an ‘object of government’, or gained material meaning and transformed into a regulatable object, by charting the standard-making process of FDA’s medical digital health policy between 2008 and 2018. From this, we reflect on the mutually sustaining dynamics between technological and organizational innovation, as the FDA’s attempts to standardize medical DHT not only shaped the lifestyle/medical boundary for DHT. It also led to significant reconfigurations within the FDA itself, while fostering a broader shift toward the uptake of alternative forms of evidence in regulatory science.

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“…The discursive notion of “disruption” is used by proponents of personalized medicine to denote these effects on existing medical approaches, yet this use has practical consequences. 42 As reflected above, two types of logics are experienced as disrupted: the “logical way” of connecting disease to gene expression results on arm B (i.e. clinical–human interpretation of data) and the digital and statistical logics of processing data and representing results (embodied in the trial’s artifacts and the workflow designated for using them).…”

Section: Molecular Data and Disruption Of Clinical Decision-makingmentioning

confidence: 99%

Data ambiguity and clinical decision making: A qualitative case study of the use of predictive information technologies in a personalized cancer clinical trial

Chorev

2019

Health Informatics J

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Personalized medicine aims to tailor the treatment to the specific characteristics of the individual patient. In the process, physicians engage with multiple sources of data and information to decide on a personalized treatment. This article draws on a qualitative case study of a clinical trial testing a method for matching treatments for advanced cancer patients. Specialists in the trial used data and information processed by a specifically developed drug-efficacy predictive algorithm and other information artifacts to make personalized clinical decisions. While using high-resolution data in the trial was expected to provide a more accurate basis for action, sociomaterial engagements of oncologists with data and its representation by artifacts paradoxically hindered personalized clinical decisions. I contend that the engagement between human discretion, ambiguous data, and malleable artifacts in this non-standardized trial produced moments of contradiction within entanglement. Sociomaterial approaches should acknowledge such conflicts in further analyses of medical practice transitions.

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Opening the Regulatory Black Box of Clinical Cancer Research: Transnational Expertise Networks and “Disruptive” Technologies

Cited by 17 publications

References 62 publications

“Medical Cannabis” as a Contested Medicine: Fighting Over Epistemology and Morality

“Medical Cannabis” as a Contested Medicine: Fighting Over Epistemology and Morality

The FDA’s standard-making process for medical digital health technologies: co-producing technological and organizational innovation

Data ambiguity and clinical decision making: A qualitative case study of the use of predictive information technologies in a personalized cancer clinical trial

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