#IDEA-FAST is exploring the possibility of regulatory qualification for proposed cross-disease digital measures. Typically a measure is qualified per disease/condition, but we are exploring what is required to qualify a cross-disease digital measure!
We share some insights in this paper from a qualification advice process with the European Medicines Agency (EMA)--useful for anyone else considering this challenge:
https://karger.com/dib/article/7/1/132/862649/Regulatory-Qualification-of-a-Cross-Disease
#DigitalHealth #DigitalBiomarker #DigitalMeasure
Regulatory Qualification of a Cross-Disease Digital Measure: Benefits and Challenges from the Perspective of IMI Consortium IDEA-FAST
Abstract. Background: Innovative Medicines Initiative (IMI) consortium IDEA-FAST is developing novel digital measures of fatigue, sleep quality, and impact of sleep disturbances for neurodegenerative diseases and immune-mediated inflammatory diseases. In 2022, the consortium met with the European Medicines Agency (EMA) to receive advice on its plans for regulatory qualification of the measures. This viewpoint reviews the IDEA-FAST perspective on developing digital measures for multiple diseases and the advice provided by the EMA. Summary: The EMA considered a cross-disease measure an interesting and arguably feasible concept. Developers should account for the need for a strong rationale that the clinical features to be measured are similar across diseases. In addition, they may expect increased complexity of study design, challenges when managing differences within and between disease populations, and the need for validation in both heterogeneous and homogeneous populations. Key Messages: EMA highlighted the challenges teams may encounter when developing a cross-disease measure, though benefits potentially include reduced resources for the technology developer and health authority, faster access to innovation across different therapeutic fields, and feasibility of cross-disease comparisons. The insights included here can be used by project teams to guide them in the development of cross-disease digital measures intended for regulatory qualification.
š°The Ā« 1 Million Dollar Question Ā» of the day: What is a #DigitalBiomarker?
Welll, no one really seems to agreeā¦ That is a bummer!
We need to do better for such a critical definition. We need official guidance and a consensus on the definition.
See this new systematic mapping and review
ā ļø Not yet peer-reviewed ā ļø.
The preprint @medrxivpreprint https://www.medrxiv.org/content/10.1101/2023.09.01.23294897v1
#DigitalBiomarkers #Research #DigitalHealth #AI #HealthTech
Definitions of digital biomarkers: a systematic mapping of the biomedical literature
Background Technological devices such as smartphones, wearables, sensors, or virtual assistants allow to collect data on health and disease processes and are thus increasingly considered a useful digital alternative to conventional biomarkers. We aimed to provide a systematic overview of the emerging literature on "digital biomarkers" with their definitions, features, and citations in biomedical research. Methods We analyzed all articles in PubMed that used the term "digital biomarker(s)" in title or abstract, considering any study involving humans and any review, editorial, perspective, or other opinion-based article up to 8 March 2023. We systematically extracted characteristics of publications and research studies, and any definitions and features of "digital biomarkers" mentioned. We described the most influential literature on digital biomarkers and their definitions using thematic categorizations of definitions considering the FDA BEST framework (i.e., data type, data collection method, purpose of biomarker), analysing the structural similarity of definitions by performing text analyses (hierarchical clustering on the distance-matrix) and citation analyses (based on citation metrics obtained from OpenAlex via Local Citation Network; last search 26 June 2023). Results We identified 415 articles prominently using the term "digital biomarker". They were published between 2014 and 2023 (median 2021), mostly describing primary research (283 articles; 68%). Most articles did not provide a definition of a digital biomarker (n=287; 69%). The 128 articles providing a definition of a digital biomarker reported 127 different definitions. Of these 127 definitions, 78 considered data collection, 56 data type, 50 the purpose, and 23 were based on all three key components. The 128 articles with a definition were cited a median of 6 times (interquartile range 2-20) with up to 517 citations. Of the ten most frequently cited articles using a definition, all used a different one. Conclusions The most frequently used definitions for digital biomarkers are highly different and there is no consensus about what this emerging term means. Our overview highlights key defining characteristics of digital biomarkers which can inform the development of a harmonized and more widely accepted definition.
### Competing Interest Statement
RC2NB (Research Center for Clinical Neuroimmunology and Neuroscience Basel) is supported by Foundation Clinical Neuroimmunology and Neuroscience Basel. All authors declare no competing interests.
### Funding Statement
No specific funding.
### Author Declarations
I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.
Yes
I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.
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I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).
Yes
I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.
Yes
All data that has been analyzed is provided in the supplementary material S2.
Trial to Assess At-Home Asthma Lung Function Tests
A clinical trial is set to begin that compares monitoring of #lung functions in people with #asthma using portable #ultrasound and mobile app at home to conventional tests in a clinic.
https://sciencebusiness.technewslit.com/?p=44341
#News #Science #Business #ClinicalTrial #Spirometry #Software #CloudComputing #Algorithms #DigitalBiomarker #Smartphone #LABA
Trial to Assess At-Home Asthma Lung Function Tests
A clinical trial is set to begin that compares monitoring of lung functions in people with asthma using portable ultrasound and mobile app at home to conventional tests in a clinic.
Christopher Bull
Dr Guy Fagherazzi, MSc, PhD
Alan Kotok