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Tackney, Mia S., Steele, Amber, Newman, Joseph, Fritzsche, Marie-Christine, Lucivero, Federica, Khadjesari, Zarnie 
ORCID: https://orcid.org/0000-0002-2958-9555, 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. and Villar, Sofía S.
(2024)
Digital endpoints in clinical trials: Emerging themes from a multi-stakeholder Knowledge Exchange event.
Trials, 25.
ISSN 1745-6215
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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.
| Item Type: | Article |
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| Additional Information: | Funding information: The Knowledge Exchange event on Digital Endpoints was supported by funding from All Council Harmonised IAA Rapid Response Award; NIHR Cambridge Biomedical Research Centre (NIHR203312) and Cambridge Centre for Data-Driven Discovery. MST and SSV acknowledge funding and support from the UK Medical Research Council (grant MC UU 00002/15 and MC UU 00040/03) and MT acknowledges Fellowship Track funding. JN received a British Heart Foundation Clinical Research Training Fellowship. MCF received funding from INTERVENE (INTERnational consortium for integratiVE geNomics prEdiction), a project that has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No. 101016775. MCF also received funding from BIOMAP (Biomarkers in Atopic Dermatitis and Psoriasis) as part of the Horizon 2020 Framework Programme: a project funded by the Innovative Medicines Initiative 2 Joint Undertaking under Grant Agreement No. 821511. H2020-EU.3.1.—SOCIETAL CHALLENGES—Health, demographic change and well-being. H2020-EU.3.1.7.—Innovative Medicines Initiative 2 (IMI2). Topic: IMI2-2017–13-02—Genome-Environment Interactions in Inflammatory Skin Disease. FL received funding from the RADAR-AD project, which received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No. 806999. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA and Software AG. This communication reflects the views of the RADAR-AD consortium, and neither IMI nor the European Union and EFPIA are liable for any use that may be made of the information contained herein. JRC received funding from the UK Medical Research Council (grant MC UU 00004/07). CHLH is funded by IDEA-FAST. MAK is funded by a personal Clinical Research Fellowship from Alzheimer's Society. FV received an MRC Experimental Medicine Award (MR/W026279/1). |
| Uncontrolled Keywords: | clinical trials,digital endpoints,digital health technology,multi-stakeholder engagement,medicine (miscellaneous),pharmacology (medical) ,/dk/atira/pure/subjectarea/asjc/2700/2701 |
| Faculty \ School: | Faculty of Medicine and Health Sciences > School of Health Sciences |
| UEA Research Groups: | Faculty of Medicine and Health Sciences > Research Centres > Norwich Institute for Healthy Aging Faculty of Medicine and Health Sciences > Research Centres > Lifespan Health Faculty of Medicine and Health Sciences > Research Groups > Behavioural and Implementation Science Faculty of Medicine and Health Sciences > Research Groups > Health Promotion |
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| Depositing User: | LivePure Connector |
| Date Deposited: | 06 Aug 2024 08:30 |
| Last Modified: | 17 Oct 2024 00:29 |
| URI: | https://ueaeprints.uea.ac.uk/id/eprint/96159 |
| DOI: | 10.1186/s13063-024-08356-7 |
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