Provides a multi-stakeholder perspective on the regulatory qualification and impact of novel digital endpoints like SV95C for Duchenne Muscular Dystrophy drug development.
Stakeholder perspectives on SV95C may guide DMD endpoint selection; leaves open regulatory qualification and clinical adoption.
Focusing on SV95C as a key example, we describe perspectives of multiple stakeholders on the promise of novel digital endpoints in neuromuscular disease drug development.
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Servais et al. (2021) studied this question.
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