Evidence map›Paper›PMID 39095915›Full record

ArticleTrials2024

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

Mia S Tackney, Amber Steele, Joseph Newman, Marie-Christine Fritzsche, Federica Lucivero, Zarnie Khadjesari, Jennifer Lynch, Rosemary A Abbott, Vicki S Barber, James R Carpenter and 18 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Article
  2. Observational
  3. Article
  4. Review
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

28 authors.

Mia S TackneyMRC-Biostatistics Unit, University of Cambridge, Cambridge, UK. mst35@cam.ac.uk.ORCID http://orcid.org/0000-0003-3868-0550
Amber SteeleStrategic Funding Partnerships Hub (SFPH), Cambridge University Hospitals, Cambridge, UK.
Joseph NewmanDepartment of Medicine, University of Cambridge and Royal Papworth Hospital, Cambridge, UK.
Marie-Christine FritzscheInstitute of History and Ethics in Medicine, TUM School of Medicine and Health, Technical University of Munich, Munich, Germany.
Federica LuciveroEthox Centre, Nuffield Department of Population Health, University of Oxford, Oxford, UK.
Zarnie KhadjesariSchool of Health Sciences, University of East Anglia, Norwich, England.
Jennifer LynchUniversity of Hertfordshire, Hatfield, UK.
Rosemary A AbbottICON PLC, Reading, UK.
Vicki S BarberOxford Clinical Trials Research Unit (OCTRU), University of Oxford, Oxford, UK.
James R CarpenterMRC Clinical Trials Unit at University College London, London, UK.
Bethan CopseyLeeds Clinical Trials Research Unit, University of Leeds, Leeds, UK.
Elin H DaviesAparito, a wholly owned subsidiary company of Eli Lilly and Company, Wrexham, Wales, UK.
William G DixonCentre for Epidemiology Versus Arthritis, Manchester Academic Health Sciences Centre, University of Manchester, Manchester, UK.
Lisa FoxClinical Trials and Statistics Unit (ICR-CTSU), The Institute of Cancer Research, London, UK.
Javier GonzálezMicrosoft Research Cambridge, Cambridge, UK.
Jessica GriffithsClinical Trials and Statistics Unit (ICR-CTSU), The Institute of Cancer Research, London, UK.
Chloe H L HinchliffeTranslational and Clinical Research Institute, Newcastle University, Newcastle, UK.
Magdalena A KolankoUK Dementia Research Institute Care Research and Technology Centre, London, UK.
Dylan McGaghNuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
Aryelly RodriguezThe University of Edinburgh, Edinburgh, UK.
George RoussosSchool of Computing and Mathematical Sciences, Birkbeck College, University of London, London, UK.
Karen B E SoAlexion Rare Oncology, AstraZeneca, Cambridge, UK.
Louise StantonSouthampton Clinical Trials Unit, University of Southampton, Southampton, UK.
Mark ToshnerRoyal Papworth Hospital and Department of Medicine, Victor Phillip Dahdaleh Heart and Lung Research Institute, University of Cambridge, Cambridge, UK.
Frances VarianUniversity of Sheffield, Sheffield, UK.
Paula R WilliamsonInstitute of Population Health, University of Liverpool, Liverpool, UK.
Belay B YimerCentre for Epidemiology, University of Manchester, Manchester, UK.
Sofía S VillarMRC-Biostatistics Unit, University of Cambridge, Cambridge, UK.

Funding

Horizon 2020 Framework Programme 101016775HORIZON EUROPE Framework Programme 821511Innovative Medicines Initiative 2 Joint Undertaking 806999Medical Research Council MC UU 00002/15Medical Research Council MC UU 00004/07Medical Research Council MC UU 00040/03MRC Experimental Medicine Award MR/W026279/1NIHR Cambridge Biomedical Research Centre NIHR203312
6 · The paper itself

Abstract

backgroundDigital 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.

methodsA 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.

resultsSeveral 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.

conclusionsThe 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.

Indexed as

Clinical Trials as TopicEndpoint DeterminationStakeholder ParticipationCooperative BehaviorHumansInterdisciplinary CommunicationMobile ApplicationsResearch DesignSmartphoneWearable Electronic DevicesClinical trialsDigital endpointsDigital health technologyMulti-stakeholder engagement

Identifiers

PMID39095915
PMCPMC11297702

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.