Practice-Based Research Network Infrastructure Design for Institutional Review Board Risk Assessment and Generalizability of Clinical Results

Abstract

Data from clinical studies generated by Practice Based Research Networks should be generalizable to the profession. For nationally representative data a broad recruitment of practitioners may pose added risks to IRB's. Infrastructure must assure data integrity while minimizing risk to assure that the clinical results are generalizable. The PEARL Network is an interdisciplinary dental/medical PBRN conducting a broad range of clinical studies. The infrastructure is designed to support the principles of Good Clinical Practice (GCP) and create a data audit trail to ensure data integrity for generalizability. As the PBRN concept becomes of greater interest, membership may expand beyond the local community, and the issue of geography versus risk management becomes of concern to the IRB. The PEARL Network describes how it resolves many of the issues related to recruiting on a National basis while maintaining study compliance to ensure patient safety and minimize risk to the IRB.

Practice Based Research Networks Impacting Periodontal Care: PEARL Initiative

“…Many networks accept all practitioners who apply without a formal review of practitioner credentials. 16 Without credentialing, a network may have a practitioner participating in a study nullifying the clinical data from that practitioner due to license restrictions. An example of license restrictions would be when a state board of dentistry limits the practitioner from performing endodontics, where that practitioner includes patients and data in an endodontic study.…”

Person‐centric clinical trials: Ethical challenges in recruitment and data transparency for improved outcomes

“…Rather, studies should reflect outcomes based on practitioner use in real‐world settings . PBTNs have been shown to be effective to generate point‐of‐care‐use data when the infrastructure is designed with risk assessment oversight for IRB compliance and for data generalizability . Including the person in clinical assessment has added value to the traditional exclusivity of the top‐down provider‐only approach of interpreting clinical results.…”

Person‐centric clinical trials: An opportunity for the good clinical practice (GCP)‐practice‐based research network

“…External audits are performed by independent contractors, while internal audits are conducted by a number of departments including: quality assurance, clinical research, operations group, staff at the study site, and regulatory affairs. PBRNs have been shown to be effective to generate point‐of‐care‐use data when the infrastructure is designed with immediate and long‐term risk assessment and oversight for IRB compliance and data generalizability …”

“…[Correction added on July 25, 2013, after first online publication: In the preceding sentence the word, date, was corrected to data.] The detailed relationship that PEARL established with the NYU IRB has been reported elsewhere . The clinical outcomes may well become limited and restricted to effectiveness studies using only approved treatments.…”

“…Practitioners Engaged in Applied Research and Learning (PEARL), a GCP PBRN network located at New York University, distinguishes the term "subject," which is a person involved in a drug development clinical trial, from a "patient," who participates in a PBRN patient (patient)-centered clinical study. 4 PBRNs represent collaboration between academic health science center(s) and community practitioners for conducting clinical studies, quality assurance, and other factors to change practice patterns, improve patient care and balance science with clinical relevance. 5 We further delineate person-centricity in the context of the person versus patient for continuity of care and the personal outcomes of health care treatments.…”