Person-centric clinical trials: defining the N-of-1 clinical trial utilizing a practice-based translational network.
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.
PEARL, Translational Network, 3 Powell Road, Emerson, N.J. 07630; New York University, New York, NY 10010, USA.
Frederick A
FA
Curro
PEARL, Translational Ethics & Policy, 130 Evergreen Ave., Imperial Beach, CA 91932, USA.
Dennis A
DA
Robbins
PEARL, New York University School of Medicine, Department Obstetrics & Gynecology 180 Varick Street, New York, NY 10014, USA.
Frederick
F
Naftolin
PEARL, 421First Ave., New York, NY 10010, USA.
Ashley C
AC
Grill
The EMMES Corp., 401N. Washington St., Rockville, MD 20850, USA.
Don
D
Vena
PEARL New York University, 421 First Ave., New York, NY 10010, USA.
Louis
L
Terracio
clinical trials; comparative effectiveness; healthcare infrastructure; patient-reported outcomes; person-centric; regulatory change