Symposium Title: Preference Evidence for Regulatory Decisions

Symposium Title: Preference Evidence for Regulatory Decisions Patient (2018) 11:467–473 https://doi.org/10.1007/s40271-018-0311-y COMMENTARY 1 1 2 3 • • • • Juan Marcos Gonzalez F. Reed Johnson Bennett Levitan Rebecca Noel Holly Peay Published online: 30 May 2018 Springer International Publishing AG, part of Springer Nature 2018 considerable interest in patient-centered decision-making, 1 Introduction it is still unclear how preference data should be integrated into existing regulatory procedures and criteria for new Interest in regulatory use of patient-preference information drug or device applications. It is also currently unclear has been growing in recent years [1–3]. Several initiatives what differences we should expect to see in regulatory have sought to help guide the collection, analysis, and outcomes from incorporating preference information. The interpretation of such information [4–6]. These initiatives evolving landscape on using preference information in the have taken place in the context of a broader evolution in regulatory context has raised the need to continue an open regulatory science and benefit–risk evaluations [3, 4, 7]. dialog among regulatory agencies, industry, academia, and The Center for Devices and Radiological Health (CDRH) those at the center of this movement, patients. at the United States Food and Drug Administration (FDA) In a one-day symposium at the 6th International Acad- recently http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png The Patient - Patient-Centered Outcomes Research Springer Journals

Symposium Title: Preference Evidence for Regulatory Decisions

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Publisher
Springer Journals
Copyright
Copyright © 2018 by Springer International Publishing AG, part of Springer Nature
Subject
Medicine & Public Health; Pharmacoeconomics and Health Outcomes; Quality of Life Research; Health Economics; Health Administration; Public Health
ISSN
1178-1653
eISSN
1178-1661
D.O.I.
10.1007/s40271-018-0311-y
Publisher site
See Article on Publisher Site

Abstract

Patient (2018) 11:467–473 https://doi.org/10.1007/s40271-018-0311-y COMMENTARY 1 1 2 3 • • • • Juan Marcos Gonzalez F. Reed Johnson Bennett Levitan Rebecca Noel Holly Peay Published online: 30 May 2018 Springer International Publishing AG, part of Springer Nature 2018 considerable interest in patient-centered decision-making, 1 Introduction it is still unclear how preference data should be integrated into existing regulatory procedures and criteria for new Interest in regulatory use of patient-preference information drug or device applications. It is also currently unclear has been growing in recent years [1–3]. Several initiatives what differences we should expect to see in regulatory have sought to help guide the collection, analysis, and outcomes from incorporating preference information. The interpretation of such information [4–6]. These initiatives evolving landscape on using preference information in the have taken place in the context of a broader evolution in regulatory context has raised the need to continue an open regulatory science and benefit–risk evaluations [3, 4, 7]. dialog among regulatory agencies, industry, academia, and The Center for Devices and Radiological Health (CDRH) those at the center of this movement, patients. at the United States Food and Drug Administration (FDA) In a one-day symposium at the 6th International Acad- recently

Journal

The Patient - Patient-Centered Outcomes ResearchSpringer Journals

Published: May 30, 2018

References

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