Valuations of experimental designs in proteomic biomarker experiments and traditional randomised controlled trials

ABSTRACT

This article examines the shifting conditions for biomedical knowledge production by studying trends in the design of biomedical experiments. The basic premise of the study is that the very act of establishing a research design entails a process involving a series of valuations where different values are evoked, ordered, and displaced. In focus is the articulation and ordering of what counts as central values in research design for two kinds of biomedical treatment trials, namely the traditional randomised controlled trial (RCT) and the emerging new form of biomarker trials used to assess biomarker/treatment combinations (BTTs). The empirical material consists of textbooks (RCTs) and journal articles (BTTs). We ask how these materials articulate the various scientific, medical, and economic values at play. Among the differences uncovered are a difference in relation to what counts as ethical in relation to prior knowledge, differences in the flexibility in design as well as the valuation of the risk for false positives and false negatives. More broadly, the study shows how textual accounts of different ways of producing knowledge are linked to partly different valuations of ethics, flexibility, and risk as part of establishing the research design of biomedical experiments.

KEYWORDS:

• Valuation
• knowledge production
• knowledge as a public good
• biomedical research
• clinical trials
• valuography

Acknowledgements

This paper reports a sub-study within the larger project ‘Trials of Value’ where Helgesson and Lee investigate the valuations performed in the designing of different kinds of experiments in medicine and biomedicine. The project has been made possible with a grant from Riksbankens Jubileumsfond. The authors want to thank Barbara Townley and Philip Roscoe as well as two anonymous reviewers for helpful and encouraging comments on earlier versions of this article. The article has furthermore benefited from comments on various occasions: the session ‘Clinical research in post-genomic medicine’ at 4S/EASST Copenhagen, October 2012; the workshop ‘What price creativity? A workshop on the valuing of social/public goods’ at University of St Andrews, December 2012; and the ValueS seminar within Technology and Social Change, Linköping University. In particular, we want to acknowledge comments and encouragement by Alberto Cambrosio, Andrew Hoffman, Nicole Nelson, and Teun Zuiderent-Jerak.

Disclosure statement

No potential conflict of interest was reported by the authors.

Notes on contributors

Claes-Fredrik Helgesson is professor in Technology and Social Change at Linköping University, Sweden. He works in the fields of economic sociology and science and technology studies (STS), currently in the emerging field of valuation studies which takes an interest in valuation as a social practice. He has published in Industrial Marketing Management, Marketing Theory, and Journal of Marketing Management. Helgesson is co-founder and co-Editor-in-Chief of Valuation Studies. He is co-editor with Isabelle Dussauge and Francis Lee of Value Practices in the Life Sciences and Medicine (Oxford University Press, 2015).

Francis Lee is an assistant professor in Technology and Social Change at Linköping University, Sweden. His primary research interests lie in the politics, practices, and technologies of knowledge. He has published in Science, Technology & Human Values, Science as Culture, and History and Technology. He is a member of the Editorial Board of Valuation Studies and is co-founder of the academic network Algorithms as Devices of Power and Valuation. He has co-edited Value Practices in the Life Sciences (Oxford University Press, 2015).

Lisa Lindén is a PhD candidate in Technology and Social Change at Linköping University, Sweden. Her main research interests concern politics of care, pharmaceuticals, and subjectivities. In her PhD dissertation project she studies HPV vaccination campaigns, with a focus on how digital media mediate care in this setting. She has published work on HPV vaccine advertisements in Girlhood Studies, a co-authored discussion note in Valuation Studies and a review and discussion article in Catalyst: Feminism, Theory, Technoscience.

ORCID

Claes-Fredrik Helgesson http://orcid.org/0000-0002-6074-6088

Francis Lee http://orcid.org/0000-0002-7206-2046

Lisa Lindén http://orcid.org/0000-0002-2834-0272

Notes

1. Within STS there is a long-standing tradition of doing empirical studies on the practices of medical research (Fujimura 1987; Epstein 1996; Löwy 1996; Keating & Cambrosio 2006). However, the practices of experimental research design has not been the object of extensive empirical study, which also holds for the recent and growing social sciences studies about RCTs in medicine (Fisher 2009; Petryna 2009; Sismondo 2009; Helgesson 2010; Will & Moreira 2010).

2. The growing interest in valuation can be seen in different topics, from markets, to tomato tasting (Helgesson & Kjellberg 2013; Helgesson & Muniesa 2013; Heuts & Mol 2013; Kjellberg et al. 2013).

3. http://www.agendia.com/clinical-trials-mindact/

4. The notion of clinical equipoise was introduced in the 1980s and has also been subject to some criticism in that it puts too strict restrictions on what should be considered ethically viable options.