TY - JOUR
T1 - Practice-based research networks and the mandate for real-world evidence
AU - Hall-Lipsy, Elizabeth
AU - Barraza, Leila
AU - Robertson, Christopher
N1 - Funding Information:
On the other hand, clinicians reportedly join PBRNs for camaraderie and from a desire to improve care and outcomes for their patients.144 Since the 1980s, the rate at which physicians say that research is a major part of their job has fallen precipitously.145 Yet when one is merely in the business of applying, but not generating, knowledge, medicine can begin to seem like a rote exercise in repetition --applying the same standard care over and over. In contrast, Dr. James Mold of the University of Oklahoma and Dr. Kevin Peterson of the University of Minnesota describe PBRNs as “learning communities,” which enrich the practices of their members.146 Indeed PBRN participation has been shown to positively impact the retention of providers in rural and underserved communities. In a study of 22 rural and underserved clinics in New Mexico, with 95 physicians, nurse practitioners, and physician assistants, the average length of employment was three years longer for research network members compared to nonmembers.147 When asked why they participated in such research networks, physicians said that they appreciated the “opportunity to enact quality improvement, contribution to clinical knowledge, and intellectual stimulation.”148 Financial support and long-term sustainability has been a substantial and long-term challenge for PBRNs. Most networks struggle to support themselves through grant funding, which limits long-term planning and recruitment and retention of key support personnel for research networks.149 Although funding from AHRQ and the NIH through CTSAs consistently reaches some PBRNs, other PBRNs do not receive funding and still struggle with establishing an administrative and coordination core.150
Publisher Copyright:
© 2018 American Society of Law, Medicine & Ethics.
PY - 2018/5/1
Y1 - 2018/5/1
N2 - The 21st Century Cures Act encourages the Food and Drug Administration to consider “real-world evidence” in its regulation of the safety and efficacy of drugs and devices. Many have interpreted this mandate to focus on non-randomized observational research. However, we suggest that regulatory science must also move from rarefied academic hospitals to community-based settings, where the vast majority of patients in fact receive care in the fragmented U.S. healthcare system. This move is especially important if innovations are to reach, and be validated in, more diverse populations. A solution can be found in the 183 Practiced-Based Research Networks (“PBRN”), i.e., groups of primary care clinicians and practices in all 50 states working to improve clinical care and translate research findings into practice. This symposium contribution seeks to describe some of the common shortcomings of clinical trials, explore the opportunities and challenges posed by use of real-world evidence as a basis for drug and device regulation, briefly describe the history and evolution of PBRNs, and articulate the challenges and opportunities for using PBRNs to fulfill the 21st Century Cures Act mandate for real-world evidence.
AB - The 21st Century Cures Act encourages the Food and Drug Administration to consider “real-world evidence” in its regulation of the safety and efficacy of drugs and devices. Many have interpreted this mandate to focus on non-randomized observational research. However, we suggest that regulatory science must also move from rarefied academic hospitals to community-based settings, where the vast majority of patients in fact receive care in the fragmented U.S. healthcare system. This move is especially important if innovations are to reach, and be validated in, more diverse populations. A solution can be found in the 183 Practiced-Based Research Networks (“PBRN”), i.e., groups of primary care clinicians and practices in all 50 states working to improve clinical care and translate research findings into practice. This symposium contribution seeks to describe some of the common shortcomings of clinical trials, explore the opportunities and challenges posed by use of real-world evidence as a basis for drug and device regulation, briefly describe the history and evolution of PBRNs, and articulate the challenges and opportunities for using PBRNs to fulfill the 21st Century Cures Act mandate for real-world evidence.
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U2 - 10.1177/0098858818789428
DO - 10.1177/0098858818789428
M3 - Article
C2 - 30106651
AN - SCOPUS:85053531078
SN - 0098-8588
VL - 44
SP - 219
EP - 236
JO - American Journal of Law and Medicine
JF - American Journal of Law and Medicine
IS - 2-3
ER -