An overview of critical decision-points in the medical product lifecycle: Where to include patient preference information in the decision-making process?

Author:

Whichello Chiara,Bywall Karin Schölin,Mauer JonathanORCID,Stephen Watt,Cleemput Irina,Pinto Cathy Anne,van Overbeeke ElineORCID,Huys Isabelle,de Bekker-Grob Esther W.,Hermann Richard,Veldwijk Jorien

Publisher

Elsevier BV

Subject

Health Policy

Reference37 articles.

1. Public and patient involvement in health technology assessment: a framework for action;Abelson;Int J Technol Assess Health Care,2016

2. "The patient's voice in the evaluation of medicines," European Medicines Agency, Stakeholders and Communication Division;European Medicine Agency,2013

3. 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;Medical Device Innovation Consortium (MDIC),2015

4. "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;FDA,2016

5. Patient-focused benefit-risk analysis to inform regulatory decisions: the european union perspective;Mühlbacher;Value Health,2016

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