DiMe Library of Digital Endpoints: Strengths, Weaknesses, and Pathways for Improvement in Digital Health Research

Author(s)

Alves Favaro M1, De Giorgio F1, Brooks T2, Bothorel S1
1Mapi Research Trust, Lyon, France, 2Mapi Research Trust, Lyon, 69, France

Presentation Documents

OBJECTIVES: Access to a shared knowledge platform that provides validated, current, and comprehensive information on Digital Health Technology (DHT) is crucial for promotion of innovation in this field. The Digital Medicine Society (DiMe) Library of Digital Endpoints is the first industry-focused, crowdsourced database for novel medical products and applications. We seek to examine the strengths and weaknesses of this valuable resource and propose pathways for improvement.

METHODS: We reviewed the digital endpoints listed in the DiMe Library, examining the accuracy and completeness of the information through rigorous verification and cross-checking with the NIH ClinicalTrials.gov database. The library comprises DHT data submitted by industry sponsors and is organized chronologically. For each trial, we reviewed the study details including phase, therapeutic indication, sponsor, technology used, and details on digital endpoints such as concepts, endpoint positioning, and measurement type.

RESULTS: The review of the DiMe Library retrieved 389 digital endpoints from studies listed from 01/09/2005 to 18/04/2023. This is a free resource and easily searchable. We observed that 51% of the entries within the DiMe Library were missing key information such as device used. Other identified issues were classified into categories such as minor wording inconsistencies, references lacking the digital endpoint assigned, and inaccuracies on the concepts assessed.

When compared to ClinicalTrials.gov over the same timeframe, the DiMe library listed fewer digital endpoints, but more extensive details were provided on the devices used and the concepts being assessed.

CONCLUSIONS: The DiMe Library of digital endpoints is a powerful tool, providing relevant information on DHTs. However, to enhance its impact as a key resource for researchers, a clear and strict data review process is needed to ensure accuracy and consistency. Additionally, a public call fostering collaboration with device/tech companies would ensure up-to-date information in this rapidly evolving field of DHTs in clinical trials.

Conference/Value in Health Info

2023-11, ISPOR Europe 2023, Copenhagen, Denmark

Value in Health, Volume 26, Issue 11, S2 (December 2023)

Code

MT76

Topic

Medical Technologies, Study Approaches

Topic Subcategory

Literature Review & Synthesis, Medical Devices

Disease

Medical Devices, No Additional Disease & Conditions/Specialized Treatment Areas

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