What are digital cognitive biomarkers and why are they useful?

Biomarkers are important for the detection of disease-relevant information to help recruit, stratify and monitor patients, and to evaluate the safety and efficacy of compounds. Here we’ll discuss what digital biomarkers are and how they offer an opportunity to revolutionize research and drug development in psychiatric and neurological disorders. 

What is a biomarker?

A biomarker is a measurement taken from an individual that relates in some way to the incidence or development of disease. These measurements must be objective, reproducible and quantifiable, with sensitivity to natural disease progression and the effects of interventions. They are often used in drug development as clinical endpoints to determine the safety profile or benefit of new drugs 1.

Biomarkers are not new to the medical field, they have long been used to track the manifestation of diseases and determine when a treatment regimen can be deemed a success. However, the heritage of biomarkers largely revolves around physiological measures of health, such as blood glucose levels or amyloid beta positivity. More recently, digital cognitive biomarkers have gained traction as objective and valuable means of studying complex psychiatric disorders 2.

What are digital cognitive biomarkers?

Similar to physiological biomarkers, cognitive biomarkers are objective measurements that can be used to track the progression of a disease or the outcome of a treatment 3. The defining difference is that cognitive biomarkers use non-invasive behavioral performance on objective cognitive tasks as an indicator or predictor of disease status.

The digital age is recognizing the value of combining multiple complex data sources into a phenotypic signature which is used to monitor health on an individual and population-based level. These phenotypic signatures rely on multiple, interacting data sources to evaluate the risk status for the manifestation, progression, or relapse of a disease 4. This is in contrast to the historical method of using a single independent biomarker for risk identification.

How can digital cognitive biomarkers enhance clinical trials?

Within pharmaceutical trials, cognitive biomarkers have traditionally been used to determine the safety and efficacy of novel compounds. This application continues to grow and develop, with many trials now including high-frequency, daily assessments of cognition to evaluate real-world data from patients rather than infrequent in-clinic tests every 3-6 months.

More recently, the industry has recognized the added utility of digital cognitive biomarkers to help enrich patient recruitment and identify relevant candidates using remote, non-invasive methodologies which can be deployed at scale with demonstrable cost-effectiveness.

In addition, digital cognitive biomarkers hold promise for better patient stratification within trial populations for more informed sub-group analyses to better understand the characteristics of drug responders versus non-responders. For example, stratifying participants by cognitive ability provides visibility into whether those who respond have a specific cognitive signature. This can lead to a more specific drug approval for a targeted sub-population, rather than a generalized late-stage drug failure.

Digital cognitive biomarkers will revolutionize clinical trials in psychiatry

Biomarkers enable us to objectively study the incidence and progression of diseases, as well as recruit specific patient populations and stratify sub-groups. Until recently most biomarkers were invasive and overly reliant on biological processes. The intersection between healthcare and technology has made viable the creation and adoption of digital biomarkers: the collection of non-invasive behavioural data from multiple sources to create a phenotypic signature.

The complexity and heterogeneity of psychiatric and neurological conditions represents a significant opportunity to study the relationships between these data sources as novel, complex endpoints for clinical trial research.

References
  1. FDA-NIH Biomarker Working Group. BEST (Biomarkers, EndpointS, and Other Tools) Resource. Food and Drug Administration (US); 2016. http://www.ncbi.nlm.nih.gov/pubmed/27010052. Accessed July 11, 2018.
  2. Roberts S, Garralda E, Renfrew D. Schizotypal Disorder among Child and Adolescent Mental Health Services Users. J Am Acad Child Adolesc Psychiatry. 2001;40(12):1366. doi:10.1097/00004583-200112000-00005.
  3. Torous J, Keshavan M. A new window into psychosis: The rise digital phenotyping, smartphone assessment, and mobile monitoring. Schizophr Res. 2018;197:67-68. doi:10.1016/j.schres.2018.01.005.
  4. Barnett I, Torous J, Staples P, Sandoval L, Keshavan M, Onnela J-P. Relapse prediction in schizophrenia through digital phenotyping: a pilot study. Neuropsychopharmacology. 2018;43(8):1660-1666. doi:10.1038/s41386-018-0030-z.
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