期刊
SOCIAL SCIENCE & MEDICINE
卷 111, 期 -, 页码 74-83出版社
PERGAMON-ELSEVIER SCIENCE LTD
DOI: 10.1016/j.socscimed.2014.04.008
关键词
Canada; Clinical trials; Drug development; Oncology; Experimental systems; Biomarkers
资金
- Canadian Institutes for Health Research [CIHR MOP-93553]
- Fonds Quebecois de la Recherche sur la Societe et la Culture [FQRSC SE-124896, SE-164195]
- Social Sciences and Humanities Research Council of Canada [SSHRC 410-2011-2290]
- Genome Quebec
Clinical trials are often described as machine-like systems for generating specific information concerning drug safety and efficacy, and are understood as a component of the industrial drug development processes. This paper argues that contemporary clinical trials in oncology are not reducible to mere drug testing. Drawing on ethnographic fieldwork and interviews with researchers in the field of oncology from 2010 to 2013, we introduce a conceptual contrast between trials as testing machines and trials as clinical experimental systems to draw attention to the ways trials are increasingly being used to ask openended scientific questions. When viewed as testing machines, clinical trials are seen as a means to produce answers to straightforward questions and deviations from the protocol are seen as bugs in the system; but practitioners can also treat trials as clinical experimental systems to investigate as yet undefined problems and where heterogeneity becomes a means to produce novel biological or clinical insights. The rise of biomarker-driven clinical trials in oncology, which link measurable biological characteristics such as genetic mutations to clinical features such as a patient's response to a particular drug, exemplifies a trend towards more experimental styles of clinical work. These transformations are congruent with changes in the institutional structure of clinical research in oncology, including a movement towards more flexible, networked research arrangements, and towards using individual patients as model systems for asking biological questions. (C) 2014 Elsevier Ltd. All rights reserved.
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