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Person-centric clinical trials: defining the N-of-1 clinical trial utilizing a
practice-based translational network
#MMPMID25932321
Curro FA
; Robbins DA
; Naftolin F
; Grill AC
; Vena D
; Terracio L
Clin Investig (Lond)
2015[]; 5
(2
): 145-159
PMID25932321
show ga
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.
free
free
free
