Advancing the Use of Patient Preference Information as Scientific Evidence in Medical Product Evaluation: A Summary Report of the Patient Preference Workshop
present current progress on incorporating PPI into medical product benefit-risk assessments;
provide examples of how PPI can be collected, analyzed, and presented in a manner that matters to stakeholders;
explore methods for appropriate measurement, interpretation, and adoption of PPI in a regulatory context; and
identify future research and capacity needs to improve the use of PPI in a regulatory context.
The authors acknowledge the extensive contributions of the workshop planning committee, including Vishal Bhatnagar, Donna Blum-Kemelor, Michelle Campbell, Meghana Chalasani, Ebony Dashiell-Aje, Liana Fraenkel, Martin Ho, Telba Irony, Ellen Janssen, Laura Lee Johnson, Paul Kluetz, Lawrence Lin, Theresa Mullin, Mimi Nguyen, Kathryn O’Callaghan, Elektra Papadopoulos, Michelle Tarver, Million Tegenge, Audrey Thomas, Pujita Vaidya, Frank F. Weichold, Rebekah Zinn, and invited speakers, including G. Caleb Alexander, R. Scott Braithwaite, Stephanie Christopher, Andrea Ferris, Juan Marcos Gonzalez, Nancy Goodman, Cynthia Grossman, Kara L. Haas, Janel Hanmer, A. Brett Hauber, RADM Denise Hinton, Frank Hurst, Catherine Kopil, Tamar Krishnamurti, Kerry Jo Lee, Bennett Levitan, Carol Linden, Deborah A. Marshall, K. Kimberly McCleary, C. Daniel Mullins, Rebecca Noel, Elisabeth (Liz) Piault-Louis, Gregory Reaman, Matt Reaney, Joseph S. Ross, Shelby D. Reed, and Melissa West.
Compliance with Ethical Standards
This work was supported by a Center of Excellence in Regulatory Science and Innovation grant to Georgetown University, Johns Hopkins University, Mayo Clinic, Stanford University, University of California San Francisco, University of Maryland, and Yale University from the US Food and Drug Administration (grant numbers UO1FD004979, U01FD005942, U01FD005946, U01FD005938, U01FD004319).
Conflict of interest
Heather L. Benz, Ting-Hsuan (Joyce) Lee, Jui-Hua Tsai, John F.P. Bridges, Sara Eggers, Megan Moncur, Fadia T. Shaya, Ira Shoulson, Erica S. Spatz, Leslie Wilson, and Anindita Saha have no conflicts of interest that are directly relevant to the content of this article.
This article reflects the views of the authors and should not be construed to represent the FDA’s views or policies.
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