Advancing the Use of Patient Preference Information as Scientific Evidence in Medical Product Evaluation: A Summary Report of the Patient Preference Workshop

Author:

Benz Heather L.ORCID,Lee Ting-Hsuan,Tsai Jui-Hua,Bridges John F. P.,Eggers Sara,Moncur Megan,Shaya Fadia T.,Shoulson Ira,Spatz Erica S.,Wilson Leslie,Saha Anindita

Funder

U.S. Food and Drug Administration

Publisher

Springer Science and Business Media LLC

Reference26 articles.

1. Hunter NL, O’Callaghan KM, Califf RM. Engaging patients across the spectrum of medical product development: view from the US Food and Drug Administration. JAMA. 2015;314(23):2499–500.

2. Hoos A, Anderson J, Boutin M, et al. Partnering with patients in the development and lifecycle of medicines: a call for action. Ther Innov Regul Sci. 2015;49(6):929–39.

3. UCSF. Patient Preference Workshop. Advancing use of patient preference information as scientific evidence in medical product evaluation. 2018. https://pharm.ucsf.edu/cersi/pp-workshop. Accessed 15 Nov 2018.

4. US FDA. Patient preference information: voluntary submission, review in premarket approval applications, humanitarian device exemption applications, and de novo requests, and inclusion in decision summaries and device labeling. 2016. https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm446680.pdf. Accessed 15 Nov 2018.

5. Craig BM, Lancsar E, Mühlbacher AC, Brown DS, Ostermann J. Health preference research: an overview. Patient. 2017;10(4):507–10.

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