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

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.

Pragmatic randomized trials in drug development pose new ethical questions: a systematic review

“…This view is shared by different commentators, adding that informing patients about treatment options is a matter of respecting a person's dignity [30] and that the clinician or researcher must be particularly aware of the potential conflict of interest [31]. A patient must be able to trust their physician explicitly, knowing they will receive a standard of care that is not compromised by research agendas [32].…”

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

“…PEARL’s scope broadened when it moved beyond its origin and roots in dentistry to an interdisciplinary practice-based network which has expanded its infrastructure into healthcare with a published philosophy based on the concept of Person-Centricity conducting Person-Centric Clinical Trials [33]. The PEARL infrastructure allows for every clinical encounter to be considered a data point [8].…”

Practice-Based Research Networks: Integrating Clinical Data for Improved Pharmacoepidemiology

“…The Patient-Centered Medical Home initiative is one recent example of this [1]. However, its importance is not restricted to clinical care, but should also be extended to clinical research [2]. As it is well known, research is needed to improve the quality of care provided, both in the present ( Are we delivering state-of-the-art care? )…”

“…Furthermore, a tool to estimate the probability of an adverse drug reaction like the ten-item algorithm from Naranjo et al [7] should also be incorporated. Such a data repository can derive from practice-based research networks, which can indeed provide invaluable pharmacoepidemiological information [2, 8]. In order to comply with principles of good clinical practice, such data repository must not include individual pieces of information that could identify patients (e.g., name, detailed address, identification card number, etc.).…”

“…Electronic health records (EHR) are an opportunity to put into practice a proactive approach to medical information collection, not only reminding doctors to assess the effects of prescriptions at a later appointment but also by acquiring data directly at the patient level, promoting empowerment and responsibility among patients and carers [9]. This would truly be a person-centric approach to health care and research [2]. …”