Digital endpoints in clinical trials: emerging themes from a multi-stakeholder Knowledge Exchange event

作者：Mia S. Tackney, A. B. Steele, Joseph Newman, Marie-Christine Fritzsche, Federica Lucivero, Zarnie Khadjesari, Jennifer Lynch, Rosemary Abbott, Vicki S Barber, James R. Carpenter, Bethan Copsey, Elin Haf Davies, William G Dixon, Lisa Fox, Luis Javier González, Jessica Griffiths, Chloe Hinchliffe, Magdalena Kolanko, Dylan McGagh, Aryelly Rodríguez, George Roussos, Karen So, Louise Stanton, Mark Toshner, Frances Varian, Paula Williamson, Belay Birlie Yimer, Sofía S. Villar · 发表于：Trials · 年份：2024 · DOI：10.1186/s13063-024-08356-7 · 被引用次数：13 · 研究领域：Mobile Health and mHealth Applications、Digital Mental Health Interventions、Health, Environment, Cognitive Aging

BACKGROUND: Digital technologies, such as wearable devices and smartphone applications (apps), can enable the decentralisation of clinical trials by measuring endpoints in people's chosen locations rather than in traditional clinical settings. Digital endpoints can allow high-frequency and sensitive measurements of health outcomes compared to visit-based endpoints which provide an episodic snapshot of a person's health. However, there are underexplored challenges in this emerging space that require interdisciplinary and cross-sector collaboration. A multi-stakeholder Knowledge Exchange event was organised to facilitate conversations across silos within this research ecosystem. METHODS: A survey was sent to an initial list of stakeholders to identify potential discussion topics. Additional stakeholders were identified through iterative discussions on perspectives that needed representation. Co-design meetings with attendees were held to discuss the scope, format and ethos of the event. The event itself featured a cross-disciplinary selection of talks, a panel discussion, small-group discussions facilitated via a rolling seating plan and audience participation via Slido. A transcript was generated from the day, which, together with the output from Slido, provided a record of the day's discussions. Finally, meetings were held following the event to identify the key challenges for digital endpoints which emerged and reflections and recommendations for dissemination. RESULTS: Seve...