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

Autor:	Dennis A. Robbins, Frederick A. Curro, Don Vena, Frederick Naftolin, Ashley C Grill, Louis Terracio
Rok vydání:	2015
Předmět:	N of 1 trial Process management business.industry Process (engineering) Interface (computing) General Medicine Transparency (behavior) Article Clinical trial Clinical research Informed consent Medicine business Quality assurance
Zdroj:	Clinical Investigation. 5:145-159
ISSN:	2041-6806 2041-6792
DOI:	10.4155/cli.14.126
Popis:	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.
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_dedup___::044b74841aa8399abeb4fd99d20f81c3 https://doi.org/10.4155/cli.14.126 Zobrazit plný text záznamu