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Real-World Data: Policy Issues Regarding their Access and Use

Basu, Anirban PhD; Axelsen, Kirsten MS; Grabowski, David C. PhD; Meltzer, David O. MD, PhD; Polsky, Daniel PhD; Ridley, David B. PhD; Wiederkehr, Daniel MPh; Philipson, Tomas J. PhD

doi: 10.1097/MLR.0000000000000603
Point-Counterpoint
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As real-world data (RWD) in health care begin to cross over to the Big Data realms, a panel of health economists was gathered to establish how well the current US policy environment further the goals of RWD and, if not, what can be done to improve matters. This report summarizes these discussions spanning the current US landscape of RWD availability and usefulness, private versus public development of RWD assets, the current inherent bias in terms of access to RWD, and guiding principles in providing quality assessments of new RWD studies. Three main conclusions emerge: (1) a business case is often required to incentivize investments in RWD assets. However, access restrictions for public data assets have failed to generate a proper market for these data and hence may have led to an underinvestment of public RWDs; (2) Very weak empirical evidence exist on for-profit entities misusing public RWD data entities to further their own agendas, which is the basis for supporting access restrictions of public RWD data; and (3) perhaps developing standardized metrics that could flag misuse of RWDs in an efficient way could help quell some of the fear of sharing public RWD assets with for-profit entities. It is hoped that these discussions and conclusions would pave the way for more rigorous and timely debates on the greater availability and accessibility of RWD assets.

*Pharmaceutical Outcome Research and Policy Program, Department of Pharmacy, University of Washington, Seattle, WA

Pfizer Inc., New York, NY

Department of Health Care Policy at Harvard Medical School, Boston, MA

§Departments of Medicine and Economics, and the School of Public Policy Studies, University of Chicago, IL

Departments of Medicine and Health Care Management at Wharton School, University of Pennsylvania, PA

The Fuqua School of Business, Duke University, Durham, NC

#Harris School of Public Policy Studies, University of Chicago, Chicago, IL

K.A. and D.W. are employees of Pfizer, Inc. A.B., D.C.G., D.O.M., D.P., D.B.R., and T.J.P. were paid by Pfizer for their travel for meetings and time. There was no restriction to intellectual expression. All participants agree to the discussions presented in this paper and take full responsibility for them. The authors declare no conflict of interest.

Reprints: Anirban Basu, PhD, 1951 NE Pacific Street, P.O. Box 357630, Seattle, WA 98195-7630. E-mail: basua@uw.edu.

Copyright © 2016 Wolters Kluwer Health, Inc. All rights reserved.