Abstract
“Readiness cohorts” are an innovation in clinical trial design to tackle the scarcity of time and people in drug studies. This has emerged in response to the challenges of recruiting the “right” research participants at the “right time” in the context of precision medicine. In this paper, we consider how the achievement of “readiness” aligns temporalities, biologies, and market processes of pharmaceutical innovation: how the promise of “willing bodies” in research emerges in relation to intertwined economic and biological time imperatives. Drawing on long-term engagement with the field of Alzheimer’s disease prevention and interviews with researchers from academia and the pharmaceutical industry, we describe the discursive construction and practical arrangement of readiness. This paper contributes to understandings of temporal specificity, or “timing,” within prevention research and casts critical light on the way this specificity—the threshold for “trial readiness”—relates to an opaque and highly speculative drug development pipeline. Extending the study of biomedical potential, as that which holds promise but may not yet exist, we consider how absences operate in adaptive trials. By highlighting these absences (“ready for what?”), we outline an opportunity for socio-ethical research to intervene in the speculative gaps of drug development.
Highlights
Time is a scarce resource in the world of clinical trials, in which timelines for recruiting and conducting trials present significant challenges (Montgomery 2017)
We show how the promise of “willing bodies” in research emerges in relation to intertwined economic and biological time imperatives in drug development: the pursuit of a future in which disease is caught “early” and progression stopped “quickly.”
We have analyzed the threshold for becoming trial-ready in terms of its temporal specificity: the right moment for the right individual to respond optimally to a given drug. We argue that this specific threshold is determined by the biologies and psychologies of individual cohort participants, it is a more distributed achievement, involving other actors and materials such as intervention owners and the trial infrastructure itself
Summary
Time is a scarce resource in the world of clinical trials, in which timelines for recruiting and conducting trials present significant challenges (Montgomery 2017). We draw on continuous involvement in the study since its inception, and eleven expert interviews with scientific researchers (from research assistants to the study’s executive committee) and pharmaceutical industry partners, exploring perspectives on what readiness “is” and how it was being “done” throughout the EPAD infrastructure These data were generated at a crucial moment in the project, in which actors were preparing to launch a phase II clinical trial after several years of observational research on Alzheimer’s disease trajectories. We focus on one particular threshold shift and contextualize it among the moving parts of the study
Sign-in/Register to view highlights & summary Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
