In the rapidly evolving landscape of healthcare, digital biomarkers are emerging as a transformative force. These advanced tools promise to revolutionize how we diagnose, monitor, and treat diseases, offering unprecedented precision and personalization.
What are digital biomarkers?
As by EMA’s definition, Digital Biomarkers (DBs) are “objective, quantifiable measure of physiology and/or behaviour used as an indicator of biological, pathological process or response to an exposure or an intervention that is derived from a digital measure. The clinical meaning is established by a reliable relationship to an existing, validated endpoint.”
Unlike traditional biomarkers, which might involve blood tests or imaging studies, digital biomarkers leverage every day or specialized technology, such as smartphones or wearables, to capture health-related data in real-time and in natural settings. This continuous and remote data collection offers a more comprehensive view of a patient’s health status, early detection in health markers and enhancing the accuracy in measuring disease progression1.
Examples:
- Activity levels – Metrics such as step count, heart rate variability, and sleep patterns tracked through wearables like Fitbit or Apple Watch.
- Speech and eye movement patterns – Changes in voice, speech or even eye movement patterns can be measured and analysed to monitor neurological conditions like Alzheimer’s disease.
- Gait and mobility – Using sensors to measure walking speed and movement can be used for tracking neuromotor diseases like multiple sclerosis.
- Cognitive function – Apps and games are designed to evaluate cognitive performance.
Applications of digital biomarkers
As mentioned before, the potential of digital biomarkers lies in their ability to provide a continuous, real-world evidence of health, leading to earlier diagnosis, more accurate monitoring, and personalized treatment. For those reasons, the integration of digital biomarkers into healthcare and clinical research is gaining momentum and are being used across various domains2. Here are some applications:
- Clinical trials – The application of DBs in clinical trials not only enhances patient convenience by facilitating remote monitoring of participants, but also improves data accuracy and reduces trial costs.
- Disease management – For chronic conditions digital biomarkers enable continuous monitoring and timely interventions.
- Diagnosis / early screening – As an example, in diseases such as Parkinson’s or Alzheimer’s, digital biomarkers help in early detection and monitoring disease progression. For example, changes in gait and speech can be early indicators of Parkinson’s, enabling earlier and more effective interventions.
Current and future challenges
- Data privacy and security – The rise of wearable devices, mobile apps, and other digital health technologies has led to a surge in personal health data being stored electronically. This data, covering everything from heart rates to sleep patterns and medication adherence, offers great potential for healthcare improvements. However, it also raises serious concerns about data breaches, unauthorized access, and misuse.
- Regulatory hurdles – Navigating the regulatory landscape can be complex and long-lasting, as digital biomarkers must meet rigorous standards to gain approval and validation frameworks are still currently being designed.
- Interoperability – Ensuring that digital biomarkers can seamlessly integrate with existing healthcare systems is crucial for their adoption.
- User engagement – Maintaining patient engagement with digital health tools over the long term can be challenging, particularly for those with low technological literacy.
Key milestones in digital biomarker development
With the emergence of digital biomarkers in the healthcare space, opportunities and challenges arise, and with them the need to validate and demonstrate their effective, safe, and positive health and business outcomes. Indeed, a recently published paper3 by DiME Society and Tufts demonstrated substantial ROI associated with the use of digital endpoints in clinical trials.
In the last couple of years, we have been witnessing key milestones showcasing the potential and sustained growth in the use of digital measures as efficacy endpoints:
- In 2022, FDA accepted of digitally measured moderate to vigorous physical activity (MVPA) as the primary endpoint in Bellerophon Therapeutics’ Phase 3 clinical trial for the treatment of Fibrotic Interstitial Lung Disease4.
- In August 2023, Sysnav Healthcare saw their SV95C being qualified by EMA as the first-ever digital endpoint for use as a primary endpoint in pivotal frug trials in Duchenne Muscular Dystrophy5.
- Fresh out of oven, Apple recently (May2014) received FDA approval for a digital biomarker aimed at monitoring atrial fibrillation through the Apple Watch as a secondary efficacy endpoint in clinical trials of cardiac ablation6.
As stated by DiME, these milestones in digital clinical measures aren’t just about the sophisticated sensors and sexy algorithms. They show we’re getting closer to using tools that make a difference for patients by reducing their burden and driving inclusivity. These tools gather the most important data about patients’ diseases, helping doctors and scientists make better decisions. Plus, they give a fuller picture of what patients go through, not just the limited info we get from brief clinic visits.
In addition, these milestones are evidence to the power and need for collaboration to advance in the field of digital biomarkers. Companies are increasingly partnering with tech firms, research institutions, and healthcare providers to develop and validate new biomarkers. Pharmaceutical companies are no exception and throughout the world they are collaborating with tech companies to enhance clinical trial data collection.
Stay tuned to Ferrer4Future news for more updates on our latest developments, partnerships, and breakthroughs in the world of digital biomarkers!
If you are developing innovative digital biomarkers with the potential to transform clinical trials, we’d love to hear from you!