Insights from the European Medicines Agency on digital health technology derived endpoints

Keerti D. Jadoenathmisier; Helga Gardarsdottir; Peter G.M. Mol; Anna M.G. Pasmooij

doi:10.1016/j.drudis.2025.104388

Insights from the European Medicines Agency on digital health technology derived endpoints

Keerti D. Jadoenathmisier
, Helga Gardarsdottir
, Peter G.M. Mol
, Anna M.G. Pasmooij^*

^*Corresponding author for this work

Research output: Contribution to journal › Short survey › peer-review

Abstract

This study evaluates the use of digital health technologies (DHTs) for endpoint measurement in clinical trials, as documented in the Qualification Opinions, Qualification Advice, and Scientific Advice procedures issued by the European Medicines Agency (EMA) between 2013 and 2022. Accelerometers are the most proposed DHTs, followed by glucose monitors and smartphones. Accelerometers are often proposed for nervous system diseases to support mobility measures and objective testing. Most DHTs were proposed for efficacy endpoints. The feedback provided by EMA emphasizes the importance of validation, precision, and a clearly defined context of use. The EMA's recent action plan further supports advancing DHT methodologies in clinical trials.

Original language	English
Article number	104388
Journal	Drug Discovery Today
Volume	30
Issue number	6
DOIs	https://doi.org/10.1016/j.drudis.2025.104388
Publication status	Published - Jun 2025

Bibliographical note

Publisher Copyright:
© 2025 The Author(s)

Keywords

Decentralized trial elements
Digital biomarkers
Digital health technologies
European Medicines Agency
Remote monitoring technologies

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10.1016/j.drudis.2025.104388Licence: CC BY

1-s2.0-S1359644625001011-mainFinal published version, 963 KBLicence: CC BY

Cite this

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title = "Insights from the European Medicines Agency on digital health technology derived endpoints",

abstract = "This study evaluates the use of digital health technologies (DHTs) for endpoint measurement in clinical trials, as documented in the Qualification Opinions, Qualification Advice, and Scientific Advice procedures issued by the European Medicines Agency (EMA) between 2013 and 2022. Accelerometers are the most proposed DHTs, followed by glucose monitors and smartphones. Accelerometers are often proposed for nervous system diseases to support mobility measures and objective testing. Most DHTs were proposed for efficacy endpoints. The feedback provided by EMA emphasizes the importance of validation, precision, and a clearly defined context of use. The EMA's recent action plan further supports advancing DHT methodologies in clinical trials.",

keywords = "Decentralized trial elements, Digital biomarkers, Digital health technologies, European Medicines Agency, Remote monitoring technologies",

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doi = "10.1016/j.drudis.2025.104388",

language = "English",

volume = "30",

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AU - Jadoenathmisier, Keerti D.

AU - Gardarsdottir, Helga

AU - Mol, Peter G.M.

AU - Pasmooij, Anna M.G.

PY - 2025/6

Y1 - 2025/6

N2 - This study evaluates the use of digital health technologies (DHTs) for endpoint measurement in clinical trials, as documented in the Qualification Opinions, Qualification Advice, and Scientific Advice procedures issued by the European Medicines Agency (EMA) between 2013 and 2022. Accelerometers are the most proposed DHTs, followed by glucose monitors and smartphones. Accelerometers are often proposed for nervous system diseases to support mobility measures and objective testing. Most DHTs were proposed for efficacy endpoints. The feedback provided by EMA emphasizes the importance of validation, precision, and a clearly defined context of use. The EMA's recent action plan further supports advancing DHT methodologies in clinical trials.

AB - This study evaluates the use of digital health technologies (DHTs) for endpoint measurement in clinical trials, as documented in the Qualification Opinions, Qualification Advice, and Scientific Advice procedures issued by the European Medicines Agency (EMA) between 2013 and 2022. Accelerometers are the most proposed DHTs, followed by glucose monitors and smartphones. Accelerometers are often proposed for nervous system diseases to support mobility measures and objective testing. Most DHTs were proposed for efficacy endpoints. The feedback provided by EMA emphasizes the importance of validation, precision, and a clearly defined context of use. The EMA's recent action plan further supports advancing DHT methodologies in clinical trials.

KW - Decentralized trial elements

KW - Digital biomarkers

KW - Digital health technologies

KW - European Medicines Agency

KW - Remote monitoring technologies

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DO - 10.1016/j.drudis.2025.104388

M3 - Short survey

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SN - 1359-6446

VL - 30

JO - Drug Discovery Today

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Insights from the European Medicines Agency on digital health technology derived endpoints

Abstract

Bibliographical note

Keywords

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