Digital endpoints in clinical trials: emerging themes from a multi-stakeholder Knowledge Exchange event
Authors: Tackney Mia S. , Steele Amber , Newman Joseph , Fritzsche Marie-Christine , Lucivero Federica , Khadjesari Zarnie , Lynch Jennifer , Abbott Rosemary A. , Barber Vicki S. , Carpenter James R. , Copsey Bethan , Davies Elin H. , Dixon William G. , Fox Lisa , González Javier , Griffiths Jessica , Hinchliffe Chloe H. L. , Kolanko Magdalena A. , McGagh Dylan , Rodriguez Aryelly , Roussos George , So Karen B. E. , Stanton Louise , Toshner Mark , Varian Frances , Williamson Paula R. , Yimer Belay B. , Villar Sofía S. 
Published: August 2024

Abstract
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
Several challenges for digital endpoints were identified in the following areas: patient adherence and acceptability; algorithms and software for devices; design, analysis and conduct of clinical trials with digital endpoints; the environmental impact of digital endpoints; and the need for ongoing ethical support. Learnings taken for next generation events include the need to include additional stakeholder perspectives, such as those of funders and regulators, and the need for additional resources and facilitation to allow patient and public contributors to engage meaningfully during the event.

Conclusions
The event emphasised the importance of consortium building and highlighted the critical role that collaborative, multi-disciplinary, and cross-sector efforts play in driving innovation in research design and strategic partnership building moving forward. This necessitates enhanced recognition by funders to support multi-stakeholder projects with patient involvement, standardised terminology, and the utilisation of open-source software.