Patient 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 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 issued guidance for submitting preference infor- emy
The Patient - Patient-Centered Outcomes Research – Springer Journals
Published: May 30, 2018
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