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

Authors

  • Frederick A. Curro DMD, PhD,

    Corresponding author
    • Regulatory Affairs Bluestone Center for Clinical Research, PEARL Practice Based Research Network, College of Dentistry, New York University, New York, NY, USA
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  • Dennis A. Robbins PhD, MPH,

    1. Integrated Decisions, Ethics, Alternatives and Solutions, Imperial Beach, CA, USA
    2. Department of Health Policy, PEARL Practice Based Research Network, New York University, New York, NY, USA
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  • Michael L. Millenson BA,

    1. The Mervin Shalowitz, Kellogg School of Management, Northwestern University, Evanston, IL, USA
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  • Chester H. Fox MD,

    1. Department of Family Medicine, UNYNET Practice Research Network, University of Buffalo School of Medicine and Biomedical Sciences, Buffalo, NY, USA
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  • Frederick Naftolin MD, DPhil

    1. Department of Obstetrics and Gynecology, PEARL Research Network, School of Medicine, New York University, New York, NY, USA
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  • [Correction added on July 25, 2013, after first online publication: In the preceding author affiliations, the fourth author, was corrected to include Northwestern University.]

Corresponding Author:

Dr. Frederick A. Curro, DMD, PhD, PEARL Network, New York University, 380 2nd Ave., Suite 302, New York, NY 10010, USA

Email: fac3@nyu.edu, rcurro249@optonline.net

Abstract

Practice-based research networks (PBRNs) can function as a platform for delivery of patient-centered care consistent with the Patient Protection and Affordable Care Act. Patient-centered (centric) clinical studies encourage the patient to be an integral part of study design and outcome. The patient's electronic health record contributes to the shared national health care data set. PBRNs integrate health care data in real time at the point of care and reflect the full context of the person's health. PBRNs designed under the principles of good clinical practice (GCP) validate studies related to comparative effectiveness research and drug development. PBRNs can generate large amounts of data from known patient histories so that side effects can be assessed in their totality. The larger and more diverse number of patients recruited suggests that point-of-care-data, where both provider and patient participate in the treatment, may be more robust in that side effects, drug–drug interactions and number of concomitant medications used may be identified earlier in the development process. The GCP PBRN concept affords continuous patient information for both care and research purposes. These all contribute to an ethical approach for the pharmaceutical industry to generate clinical research data for regulatory submission and to contribute to a HIPAA-compliant national database that could contribute to improved health care delivery and pharmacovigilance.

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