Person-centric clinical trials: defining the N-of-1 clinical trial utilizing a practice-based translational network

Abstract

A person-centric clinical trial is inclusive of both the investigator and the person and as such represents point-of-use data generated at the practice level and encompasses both health and disease. Raising the clinical encounter to a research encounter and providing an infrastructure to support a level of quality assurance creates a synergy for efficiency for healthcare delivery. The interface of translational studies and clinical research poses an opportunity, whereby person-centricity can support transparency, facilitate informed consent, improve safety, enhance recruitment and compliance, improve dissemination of results, implement change and help close the translational gap. The model represents robust clinical data from persons of record allowing for improved interpretation of drug/device side-effects and for regulatory reviewers to expedite the approval process.

Keywords: clinical trials; comparative effectiveness; healthcare infrastructure; patient-reported outcomes; person-centric; regulatory change.

Figure 1. Person-centricity creates a more dynamic and involved approach to a person’s health and disease

When a person is perceived as a patient, the focus is on the disease not the person who becomes passive with little or no participation in their health and wellness outcomes.