“Ready for What?”: Timing and Speculation in Alzheimer’s Disease Drug Development

Brenman, Natassia F. and Milne, Richard. 2022. “Ready for What?”: Timing and Speculation in Alzheimer’s Disease Drug Development. Science, Technology, & Human Values, 47(3), pp. 597-622. ISSN 0162-2439 [Article]

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Abstract or Description

“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.

Item Type:

Article

Identification Number (DOI):

https://doi.org/10.1177/01622439211007196

Additional Information:

The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This work was funded through EPAD which receives support from the Innovative Medicines Initiative Joint Undertaking under grant agreement n° 115736, resources of which are composed of financial contribution from the European Union’s Seventh Framework Program (FP7/2007–2013) and EFPIA companies’ in-kind contribution.

Keywords:

clinical trials, Alzheimer’s disease, ethics, speculation, time, readiness

Departments, Centres and Research Units:

Sociology

Dates:

DateEvent
11 March 2021Accepted
22 April 2021Published Online
May 2022Published

Item ID:

29987

Date Deposited:

26 Apr 2021 08:33

Last Modified:

27 Apr 2022 13:42

Peer Reviewed:

Yes, this version has been peer-reviewed.

URI:

https://research.gold.ac.uk/id/eprint/29987

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