Practice-Based Research Networks and the Mandate for Real-World Evidence

19 Pages Posted: 23 Aug 2018

See all articles by Elizabeth Hall-Lipsy

Elizabeth Hall-Lipsy

University of Arizona College of Pharmacy

Leila Barraza

Network for Public Health Law; University of Arizona - Mel and Enid Zuckerman College of Public Health

Christopher T. Robertson

University of Arizona - James E. Rogers College of Law; Harvard University - Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics

Date Written: August 14, 2018

Abstract

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 (1) describe some of the common shortcomings of clinical trials, (2) explore the opportunities and challenges posed by use of real-world evidence as a basis for drug and device regulation, (3) briefly describe the history and evolution of PBRNs, and (4) articulate the challenges and opportunities for using PBRNs to fulfill the 21st Century Cures Act mandate for real-world evidence.

Keywords: FDA Practice-Based Research Network, PBRN, clinical trials, real-world evidence

Suggested Citation

Hall-Lipsy, Elizabeth and Barraza, Leila and Robertson, Christopher T., Practice-Based Research Networks and the Mandate for Real-World Evidence (August 14, 2018). 44 American Journal of Law and Medicine 219 (2018); Arizona Legal Studies Discussion Paper No. 18-28. Available at SSRN: https://ssrn.com/abstract=3231000

Elizabeth Hall-Lipsy

University of Arizona College of Pharmacy

College of Pharmacy
Tucson, AZ 85721
United States

Leila Barraza

Network for Public Health Law ( email )

Saint Paul, MN
United States

University of Arizona - Mel and Enid Zuckerman College of Public Health ( email )

Tucson, AZ

Christopher T. Robertson (Contact Author)

University of Arizona - James E. Rogers College of Law ( email )

P.O. Box 210176
Tucson, AZ 85721-0176
United States

HOME PAGE: http://www.law.arizona.edu/faculty/getprofile.cfm?facultyid=714

Harvard University - Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics ( email )

23 Everett Street
Cambridge, MA 02155
United States

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