Creating digital biomarkers and enabling remote medical support through data analysis
What is a Digital Biomarker?
A biomarker is a factor or substance in the body that indicates the presence or absence of a disease, changes in patient condition, or degree of treatment efficacy. Until now, these biomarker data were “point data” that were measured only when people visited a medical institution, and the presence or absence of a disease and its progress could only be determined at that time.
However, advances in digital technology have made it possible to obtain continuous, long-term "line data" on a daily basis without any stress using smartphones or wearable devices. Digital biomarkers are indicators that visualize changes in diseases and treatments based on this digital information.
If data such as exercise, sleep, and heart rate can be obtained in daily life outside of medical institutions, it will be possible to understand changes in condition in more detail and provide optimal care (personalized medicine) tailored to each individual.
Classification of Digital Biomarkers
Digital biomarkers can be classified according to their intended use.
Pharmaceutical Development & Clinical Trial Endpoint Biomarkers
Quantitatively evaluate changes in condition due to therapeutic intervention
・Quantification of symptoms
・Evaluation of biological data
(sleep, activity level, etc.)
・Evaluation of life functions / QOL
Disease Onset Prediction Biomarkers
Predict the risk or timing of disease onset
・Detection of populations at risk of disease
・Prediction of onset timing / severity
Diagnostic Aid Biomarkers
Determine the state of
the disease
・Early diagnosis / screening
・Improvement of diagnostic
accuracy
・Support for differential diagnosis
・QOL evaluation
Treatment Monitoring Biomarkers
Capture changes in disease status and treatment behaviors
・Evaluation of treatment effectiveness
・Evaluation of side effects / safety
・Understanding medication adherence (adherence)
- Medication detection using digital pills
- Estimation of medication status using biological data
Disease Prognosis Prediction Biomarkers
Predict the progression or severity of the disease
・Prediction of disease progression
・Risk assessment for complications
Practical Guidance
on the Use of Wearable Devices
in Clinical Research
Tech Doctor has published a draft document prepared by our team.
Second Edition — November 15, 2024
Tech Doctor's
Digital Biomarker Development
Features
Tech Doctor can provide support based on medical knowledge, from comparative validation (validation) with medical devices to analysis.
Use of continuous and long-term data
Having continuous, long-term data spanning two weeks or more is crucial for capturing an individual's baseline characteristics, detecting changes, and comparing them with the original condition. This enables the identification of medium- and long-term impacts of treatment or intervention.
Highly specialised analysis incorporating medical perspectives
Analysis based on medical interpretations is carried out through previous research studies and collaboration with universities and research institutions.
Numerous validation results
We perform data comparison (validation) between digital devices such as wearables and medical devices to verify data accuracy.
SelfBase – Digital Biomarker development platform
SelfBase allows you to effortlessly manage and analyze continuous, long-term data acquired from multiple wearable and medical devices. It is also possible to analyze data in conjunction with other sources of information such as questionnaires.
