Work

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

Year: 2015

Type: article

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.

Source: Clinical Investigation

DOI: 10.4155/cli.14.126

Authors: Frederick A Curro, Dennis A Robbins, Frederick Naftolin, Ashley C Grill, Don Vena, Louis Terracio

Institutions: New York University, Emmes (United States)

Language: English

Topic: Statistical Methods in Clinical Trials

Subfield: Statistics and Probability

Field: Mathematics

Domain: Physical Sciences

SDG: Good health and well-being

Open Access status: green

Funder: National Institute of Dental and Craniofacial Research