Precision patients: Selection practices and moral pathfinding in experimental oncology

Abstract

This paper addresses selection practices in a Danish phase 1 unit specialised in precision medicine in the field of oncology. Where precision medicine holds the ambition of selecting genetically fit medicine for the patient, we find that precision medicine in the early trial setting is oriented towards selecting clinically and genetically fit patients for available treatment protocols. Investigating how phase 1 oncologists experience and respond to the moral challenges of selecting patients for early clinical trials, we show that inclusion criteria and patient categories are not always transparent to patients. Lack of transparency about inclusion criteria has been interpreted as morally problematic. Yet drawing on social science studies of ‘unknowing’, we argue that silence and non‐transparency in interactions between oncologists and patients are crucial to respect the moral agency of patients at the edge of life and recognise them as belonging to the public of Danish health care. In the discussion, we consider the practice of placing ‘unfit’ patients on a waiting list for trial participation. Rather than representing an ethical and political problem, we argue, the waiting list can act as a valve enabling oncologists to navigate the scientific and as well as the moral uncertainties in phase 1 oncology.

Hope in the era of precision oncology: a qualitative study of informal caregivers’ experiences

“…The ability to access these therapies was often articulated in contrast to others who did not have this access, for example, people with different cancer types or living in places/times without these options. ‘Precision’ care was thus seen to open a new door to hope, 3 a door held open by the Australian healthcare system’s investment in and subsidising of ‘cutting-edge’ treatments. In Australia, cancer care is financed through a complex mix of Federal and State funding, private health insurance and out-of-pocket funds, and delivered by both the public and private hospital systems.…”

“… 57–59 Time-to-market, and therapeutic pipelines more broadly, take years and sometimes decades to come to fruition—if, indeed, they bear fruit at all. 60 Yet experimental precision oncology trials involving human participants who must be matched, clinically and genetically, to the requirements of the trial 3 offer a sense that medical innovation is happening in real time. In the caregivers’ accounts, biographical time competes with clinical time, 61 the pace of innovation set against the progression of disease and (almost) inevitable failure of currently available treatments.…”

“…These precision therapies differ considerably from traditional standard of care treatments such as chemotherapy 1. Although unequally available across contexts, new precision therapies have inspired renewed hope, catalysed escalating costs and produced new landscapes of side effects, patienthood and survivorship 2–6…”

Diagnosing by anticipation: Coordinating patient trajectories within and across social systems

“…Given the right circumstances, therefore, 'hard cases' (where biomedical evidence is not found wanting) can become elastic. One such situation is described in Dam et al's (2022) study of oncologists' thoughtful selection for early-stage non-curative experimental treatment, wherein terminal cancer patients were classified as 'fit' or 'unfit' for clinical trial participation. 'Fit' patients were put on the waiting list for the trial, whereas 'unfit' patients were excluded.…”

“…13 13 Dam et al. (2022) talk about the oncologists ‘unknowing’ that the patient is unfit, which, we think, is a different way of talking about how elasticity is achieved. But we add that the diagnosticians in Rasmussen’s study, not to mention in Allsopp (2017) and Whooley’s (2010) studies, seemed more knowing that unknowing that they operated in a grey area. …”