The Patient Voice: Exploring Treatment Preferences in Participants with Mild Cognitive Concerns to Inform Regulatory Decision Making

Author:

Mansfield CarolORCID,Bullok Kristin,Fuhs Jillian Venci,Tockhorn-Heidenreich Antje,Andrews J. Scott,DiBenedetti Dana,Matthews Brandy R.,Darling Joshua C.,Sutphin Jessie,Hauber Brett

Funder

Eli Lilly and Company

Publisher

Springer Science and Business Media LLC

Subject

General Engineering

Reference51 articles.

1. Medical Device Innovation Consortium. Patient centered benefit-risk project report: a framework for incorporating information on patient preferences regarding benefit and risk into regulatory assessments of new medical technology. 2015. https://mdic.org/wp-content/uploads/2018/05/MDIC_PCBR_Framework_Web.pdf. Accessed 24 Feb 2021.

2. US Food and Drug Administration. 21st Century Cures Act. https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/21st-century-cures-act. Accessed 13 Apr 2021.

3. IMI-PREFER. Innovation medicine initiative: patient preferences in benefit-risk assessments during the drug life cycle. 2016. https://www.imi-prefer.eu/about/. Accessed 24 Feb 2021.

4. European Medicines Agency. EMA regulatory science to 2025: strategic reflection. 2020. https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/ema-regulatory-science-2025-strategic-reflection_en.pdf. Accessed 17 Nov 2020.

5. Bouvy JC, Cowie L, Lovett R, Morrison D, Livingstone H, Crabb N. Use of patient preference studies in HTA decision making: a NICE perspective. Patient. 2020;13(2):145–9.

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