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From N=1 Clinical Trials to n-of-one clinical reasoning: Omics-based Personalized Medicine requires treating every patient as an n-of-1 “Natural Kind”Clinical reasoning in treating diseases such as cancer increasingly require clinicians to treat each patient as ‘truly biologically unique’ (Blau et al 2013, Topol 2014). The practices of clinical reasoning under Personalized Medicine and Omics-based Precision Medicine require clinicians to reason the modeling of the disease etiology of disease using scientific evidence from population based studies - epidemiology and randomized controlled trials - and direct measurement - molecular biomarker and omics based profiling of the individual person’s biology. Treatment planning now routinely requires the collaboration of multiple disciplinary specialties several of which were until recently in the research and explication phase of work but now are engaged in applying their epistemic practices in service of medical intervention. Epistemically this situation brings interdisciplinary scientific work into the clinic and the work of personalization of treatment planning requires these teams to rationalize the epistemes from these disciplines as it applies to the patient at hand. Clinical teams reason the course of intervention by combining - integrating and rationalizing - the characterization of the physiology and pathophysiology of the patient at hand across the scientific theories from multiple disciplines. Theories which were previously served the purposes of explication are now being used as the basis of intervention. The chief difference is that theories being developed on populations of specimens and are now being tested on one individual specimen. Thus clinical medicine by multi-disciplinary teams enacting personalized medicine are carrying out scientifically based interventions in n-of-one cases.
Such clinical teams are not merely applying reliable epistemic practices developed elsewhere but they are developing the scientific explanatory models of n-of-one case. And their success and failures represent the success and failures of their explanatory models of these n-of-one cases. Their explanatory models belong in the class of collaborative explanations (Fagan 2014) devised by scientific research programs employing overlapping and intersecting epistemic practices. Many of these explanatory models and epistemic practices have been developed up the hierarchy of evidence from epidemiological data and their integration and rationalizations explored through N=1 clinical trials. However with the extensive characterization of the n-of-one patient at hand with omics-based measurements the ‘referenced’ biological organism is held to be modelled in their biological uniqueness. And this modeling of their biological uniqueness is the standard at stake for personalized medicine practices.
This poster explores this relation between this standard of the n-of-one case as the standard of a Natural Kind and examines the status of the integrative practices of clinical teams in molecular oncology which develop ‘collaborative explanations’ to drive treatment. The gaps in the epistemic practices are enumerated to develop a fuller set of requirements for precision medicine under this standard.
Tremont Research Institute