Digital Endpoints in Regulatory Science - Possibilities and Challenges for Industry, Regulators, and Healthcare Professionals
Digital health technologies are increasingly used to remotely capture features of patients’ health for both clinical practice and clinical trials. Their use in clinical trials - as digital endpoints - offers new possibilities for drug development and patient care, including more frequent assessments, greater reliability and precision, and improved ecological validity. However, several challenges hinder the widespread adoption of digital endpoints. These include a lack of standardization, the need for new interdisciplinary collaboration, uncertain value propositions, and comprehensive data management issues. Focusing on the European regulatory framework, this webinar explores the transformative potential of digital endpoints while critically examining the challenges and implications for industry stakeholders, regulatory bodies, and healthcare professionals.
Program
13:00 - 13:05: Welcome
13:05 - 13:20: Mathias Møllebæk, Uni of Copenhagen: "Mapping European digital endpoint development - preliminary study results"
13:20 - 13:35: Steffen Thirstrup, European Medicines Agency: "Digital endpoints and decentralized trials"
13:35 - 13:50: Lada Leyens, DEEP Measures: “Accelerating collaboration, re-use and acceptance through a structured evidence framework”
13:50 - 14:05: Cathelijne de Gram, Johnson & Johnson: “Industry perspective on regulatory acceptance of digital endpoints”
14:05 - 14:30: Panel Discussion