Population-making in the regulatory arenas of clinical trials

Jakob Wested

Chapter 4 in Handbook of Pharmaceutical Science and Technology Studies, 2026, pp 59-74 from Edward Elgar Publishing

Abstract: Abstract: The same medicine can have different effects in different patients; for example children, the elderly, men, and women. Therefore representation becomes instrumental to ensure equal access to safe and effective treatment and better outcomes of medical interventions. This perspective is reflected in current discussion on representation, diversity, and inclusion in clinical trials. This chapter explores how representation of population groups in the clinical trials of medical development are contingent on political priorities, scientific paradigms, and ethical considerations. With the perspective of Foucault's concepts of biopower and governmentality, the chapter develops a theoretical framework addressing how populations are formed as a co-production of knowledge and socio-technical imaginaries (Jasanoff, 2019). A collection of historical examples of population-making show how technological breakthroughs, scientific conduct, regulatory innovations, and legal constructs have shaped the demarcation and focus on various populations. The examples may inform future discussion about populations, e.g., in relation to AI, demographic shifts, and a continued discussion of population-making and the co-production of knowledge. The chapter will primarily focus on examples, cases, and legislation from Europe. However, the theoretical framework and the basic issues of population-making at the intersection of politics, science, and ethics applies globally.

Keywords: Representation; Diversity; Boundary work; Governmentality; Evidence-based medicine; Biopower (search for similar items in EconPapers)
Date: 2026
ISBN: 9781035338443
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