Meeting Patients Where They Are: Validating Remote Digital Tools for Multi-Indication NMD Research

Описание: This webinar focused on "Meeting Patients Where They Are: Validating Remote Digital Tools for Multi-Indication NMD Research" presented by Dr. Tina Duong from Stanford University. Dr. Duong discussed the importance of using the International Classification of Function, Disability, and Health (ICF) model and the Biomarkers, Endpoints, and Other Tools (BEST) framework to validate digital health outcomes for neuromuscular diseases (NMD). The panel discussion, moderated by Dr. Ramona Belfiore-Oshan, explored common misconceptions about digital endpoints, including concerns about patient compliance and the need for FDA clearance. Participants discussed the balance between traditional clinical measures, patient-reported outcomes (PROs), and digital measures in trial design. The group addressed challenges in capturing real-world function, fatigue, and daily variability through digital tools. Looking forward, panelists envisioned that within 5 years, 50% or more of NMD clinical trials would include digital health technologies as either primary or secondary endpoints, with increased collaboration between academia, industry, and regulators to accelerate validation processes.

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About Critical Path Institute

C-Path is an independent, nonprofit established in 2005 as a public-private partnership, in response to the FDA’s Critical Path Initiative. C-Path’s mission is to lead collaborations that advance better treatments for people worldwide. Globally recognized as a pioneer in accelerating drug development, C-Path has established numerous international consortia, programs and initiatives that currently include more than 1,600 scientists and representatives from government and regulatory agencies, academia, patient organizations, disease foundations and pharmaceutical and biotech companies. With dedicated team members located throughout the world, C-Path’s global headquarters is located in Tucson, Arizona and C-Path’s Europe subsidiary is headquartered in Amsterdam, Netherlands. For more information, visit c-path.org.

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