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

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
Externally published	Yes

Bibliographical note

Other keywords

Biomedical Technology/methods
Clinical Trials as Topic
Decentralized trial elements
Digital Health
Digital Technology
Digital biomarkers
Digital health technologies
Endpoint Determination/methods
Europe
European Medicines Agency
Humans
Remote monitoring technologies

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10.1016/j.drudis.2025.104388

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 = "Biomedical Technology/methods, Clinical Trials as Topic, Decentralized trial elements, Digital Health, Digital Technology, Digital biomarkers, Digital health technologies, Endpoint Determination/methods, Europe, European Medicines Agency, Humans, Remote monitoring technologies",

author = "Jadoenathmisier, \{Keerti D.\} and Helga Gardarsdottir and Mol, \{Peter G.M.\} and Pasmooij, \{Anna M.G.\}",

note = "Publisher Copyright: {\textcopyright} 2025 The Author(s)",

year = "2025",

month = jun,

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

language = "English",

volume = "30",

journal = "Drug Discovery Today",

issn = "1359-6446",

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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 - Biomedical Technology/methods

KW - Clinical Trials as Topic

KW - Decentralized trial elements

KW - Digital Health

KW - Digital Technology

KW - Digital biomarkers

KW - Digital health technologies

KW - Endpoint Determination/methods

KW - Europe

KW - European Medicines Agency

KW - Humans

KW - Remote monitoring technologies

UR - https://www.scopus.com/pages/publications/105007158288

U2 - 10.1016/j.drudis.2025.104388

DO - 10.1016/j.drudis.2025.104388

M3 - Short survey

C2 - 40436264

SN - 1359-6446

VL - 30

JO - Drug Discovery Today

JF - Drug Discovery Today

IS - 6

M1 - 104388

ER -

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

Abstract

Bibliographical note

Other keywords

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