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.
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 (Presented at SPIE BiOS: February 03, 2020; Published: 9 March 2020); https://doi.org/10.1117/12.2563467.6138703218001.
Conference Presentations are recordings of oral presentations given at SPIE conferences and published as part of the proceedings. They include the speaker's narration with video of the slides and animations. Most include full-text papers. Interactive, searchable transcripts and closed captioning are now available for most presentations.
Search our growing collection of more than 29,500 conference presentations, including many plenaries and keynotes.