Testing devices or experimental systems? Cancer clinical trials take the genomic turn.
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 open-ended 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.
Department of the History of Science, University of Wisconsin-Madison, 1225 Linden Drive, Madison, WI 53706, USA. Electronic address: ncnelson@wisc.edu.
Nicole C
NC
Nelson
Department of History, Université du Québec à Montréal, Pavillon Lionel-Groulx, 3150 Jean-Brillant, Montréal, Quebec H3T 1N, Canada. Electronic address: keating.peter@uqam.ca.
Peter
P
Keating
Department of Social Studies of Medicine, McGill University, Peel 3647, Montreal, Quebec H3A 1X1, Canada. Electronic address: alberto.cambrosio@mcgill.ca.
Alberto
A
Cambrosio
Lady Davis Institute for Medical Research, Jewish General Hospital, 3755 Côte-Ste-Catherine, Montreal, Quebec H3T 1E2, Canada. Electronic address: nanaaguilar@gmail.com.
Adriana
A
Aguilar-Mahecha
Lady Davis Institute for Medical Research, Jewish General Hospital, 3755 Côte-Ste-Catherine, Montreal, Quebec H3T 1E2, Canada. Electronic address: mark.basik@mcgill.ca.
Mark
M
Basik
D000970:Antineoplastic Agents / Q000494:pharmacology; D054316:Biomarkers, Pharmacological; D002170:Canada; D002986:Clinical Trials as Topic / Q000379:methods*; D023281:Genomics; D006801:Humans; D009369:Neoplasms / Q000188:drug therapy*; D012107:Research Design
D000970:Antineoplastic Agents; D054316:Biomarkers, Pharmacological
Biomarkers; Canada; Clinical trials; Drug development; Experimental systems; Oncology