Patient Science Informing Regulatory Decision-Making Across the Total Product Lifecycle (Conference Presentation)

Heather Benz; Daniel X. Hammer; Michelle Tarver

doi:10.1117/12.2563467

9 March 2020 Patient Science Informing Regulatory Decision-Making Across the Total Product Lifecycle (Conference Presentation)

Heather Benz, Daniel X. Hammer, Michelle Tarver

Author Affiliations +

Proceedings Volume 11229, Advanced Biomedical and Clinical Diagnostic and Surgical Guidance Systems XVIII; 112290W (2020) https://doi.org/10.1117/12.2563467
Event: SPIE BiOS, 2020, San Francisco, California, United States

Abstract

A shift toward increased patient-centeredness is taking place in healthcare, from clinical care to medical product innovation, evaluation, and reimbursement decision-making. The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) has engaged the scientific and patient communities in developing rigorous scientific methods to integrate patient input into regulatory decision-making. This patient input comes in several forms, including patient-reported outcomes (PROs) and patient preference information (PPI). These studies have helped identify unmet needs, develop novel endpoints, improve clinical investigation design, and inform the benefit-risk assessment.

Conference Presentation

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Heather Benz, Daniel X. Hammer, and Michelle Tarver "Patient Science Informing Regulatory Decision-Making Across the Total Product Lifecycle (Conference Presentation)", Proc. SPIE 11229, Advanced Biomedical and Clinical Diagnostic and Surgical Guidance Systems XVIII, 112290W (9 March 2020); https://doi.org/10.1117/12.2563467

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