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

Autor: Tackney MS; MRC-Biostatistics Unit, University of Cambridge, Cambridge, UK. mst35@cam.ac.uk., Steele A; Strategic Funding Partnerships Hub (SFPH), Cambridge University Hospitals, Cambridge, UK., Newman J; Department of Medicine, University of Cambridge and Royal Papworth Hospital, Cambridge, UK., Fritzsche MC; Institute of History and Ethics in Medicine, TUM School of Medicine and Health, Technical University of Munich, Munich, Germany.; School of Social Sciences and Technology, Technical University of Munich, Munich, Germany., Lucivero F; Ethox Centre, Nuffield Department of Population Health, University of Oxford, Oxford, UK., Khadjesari Z; School of Health Sciences, University of East Anglia, Norwich, England., Lynch J; University of Hertfordshire, Hatfield, UK., Abbott RA; ICON PLC, Reading, UK., Barber VS; Oxford Clinical Trials Research Unit (OCTRU), University of Oxford, Oxford, UK., Carpenter JR; MRC Clinical Trials Unit at University College London, London, UK.; Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK., Copsey B; Leeds Clinical Trials Research Unit, University of Leeds, Leeds, UK., Davies EH; Aparito, a wholly owned subsidiary company of Eli Lilly and Company, Wrexham, Wales, UK., Dixon WG; Centre for Epidemiology Versus Arthritis, Manchester Academic Health Sciences Centre, University of Manchester, Manchester, UK., Fox L; Clinical Trials and Statistics Unit (ICR-CTSU), The Institute of Cancer Research, London, UK., González J; Microsoft Research Cambridge, Cambridge, UK., Griffiths J; Clinical Trials and Statistics Unit (ICR-CTSU), The Institute of Cancer Research, London, UK., Hinchliffe CHL; Translational and Clinical Research Institute, Newcastle University, Newcastle, UK., Kolanko MA; UK Dementia Research Institute Care Research and Technology Centre, London, UK.; Imperial College London, London, UK., McGagh D; Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.; Big Data Institute, Li Ka Shing Centre for Health Information and Discovery, University of Oxford, Oxford, UK., Rodriguez A; The University of Edinburgh, Edinburgh, UK., Roussos G; School of Computing and Mathematical Sciences, Birkbeck College, University of London, London, UK., So KBE; Alexion Rare Oncology, AstraZeneca, Cambridge, UK., Stanton L; Southampton Clinical Trials Unit, University of Southampton, Southampton, UK., Toshner M; Royal Papworth Hospital and Department of Medicine, Victor Phillip Dahdaleh Heart and Lung Research Institute, University of Cambridge, Cambridge, UK., Varian F; University of Sheffield, Sheffield, UK., Williamson PR; Institute of Population Health, University of Liverpool, Liverpool, UK., Yimer BB; Centre for Epidemiology, University of Manchester, Manchester, UK., Villar SS; MRC-Biostatistics Unit, University of Cambridge, Cambridge, UK.
Jazyk: angličtina
Zdroj: Trials [Trials] 2024 Aug 03; Vol. 25 (1), pp. 521. Date of Electronic Publication: 2024 Aug 03.
DOI: 10.1186/s13063-024-08356-7
Abstrakt: 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.
(© 2024. The Author(s).)
Databáze: MEDLINE
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