CRO Diaries: A Quick Guide To The Differences Between Traditional Biomarkers And Digital Biomarkers

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Biomarkers are crucial for biomedical and clinical research. Several tests use biomarkers such as blood pressure, cholesterol levels, and temperature to assess health and disease states. Moreover, traditional biomarkers are widely used during clinical trials to evaluate therapeutic effects and clinical status and predict treatment outcomes. However, incorporating biomarkers in clinical practice is a long and expensive process. Each biomarker has to travel through the discovery process, animal experimentation, clinical studies, and validation process to become a gold standard endpoint.

Today researchers use several modalities to assess clinical biomarkers in drug discovery and development. These methods include LC-mass spectrometry and Meso Scale Discovery platforms. Both LC-MS and MSD platforms are used widely in drug development studies. But what are LC-MS and MSD ELISA assays? LC-MS assays are chromatographic assays, whereas MSD is a type of immunoassay. Although different, both are used routinely to test biomarkers. Besides MSD biomarker assays, the MSD platform has alternative assays such as MSD cytokine and MSD ELISA assays.

Digital biomarkers are physiological, quantifiable, objective, and behavioral measures collected through digital devices such as wearable, portable, or implantable. Due to the upsurge in digital devices, digital biomarkers are increasingly being deployed in clinical trials and precision medicine.. Despite the similarities between digital and traditional biomarkers, they have specific differences. The current article highlights the differences between traditional and digital biomarkers.

Comparison between digital and traditional biomarkers

In theory, digital biomarkers fall in the traditional biomarker category. This similarity is because digital biomarkers address health-related questions with the help of digital devices.

Traditional biomarkers are well established within the clinical and research landscape. They can be qualitative or quantitative. Besides, they are often limited in their complexity. However, they can be expensive and invasive in use. Also, due to the complexity involved in disease and medical conditions, traditional biomarkers often need more to depict  the whole picture.

On the other hand, digital biomarkers are relatively less invasive, inexpensive, and often modular. They can produce quantitative and qualitative measurements. Most importantly, they provide a cheaper and easier alternative to longitudinal data. However, digital biomarkers are still a new domain and have yet to be widely used in clinical practice and research.  The primary reason for its uncommon use is  that digital biomarkers measure characteristics distally and produce large data sets that can be challenging for analysis. Moreover, hardware malfunctions, multiple interpretations, reliability, and baseline determinations are some additional drawbacks for digital biomarkers.

The baseline objective of traditional biomarkers is to assess or improve the health status of a particular population. However, for digital biomarkers, the application landscape is much broader. Digital biomarkers have three different study groups:

  1. Curiosity, casual, or fitness-based group
  2. Commercial-based group 
  3. Clinical trial and regulatory group.

Despite these differences, all three digital biomarker groups can provide crucial data regarding the health status of the population, which can be translated further for biomarker validation. Hence, all relevant stakeholders must recognize these differences and work together towards a standardized approach for digital biomarkers.

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