Digital biomarkers measured by wearables, sensors and other digital devices are increasingly playing a key role in the healthcare sector by enabling remote monitoring of diseases and even clinical trial patients.

Verdict has conducted a poll to assess which of the markers measured by digital health technologies have the most potential for use in clinical trials. Respondents were allowed to choose from one of the five markers namely heart rate, respiration patterns/rate, physical activity, medication adherence, and sleep.

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Analysis of the poll responses shows that heart rate and respiration patterns/rate have the most potential for immediate use in clinical trials, according to 29% and 24% of the respondents, respectively.

Markers such as physical activity and medication adherence were chosen by 19% and 17% of the respondents respectively, while a lesser 11% of the respondents voted for sleep as having the most potential for immediate use in clinical trials.

Heart rate and respiration patterns measured digitally have the most potential for immediate useThe analysis is based on 280 responses received from the readers of Clinical Trials Arena, a Verdict network site, between 08 February and 18 May 2021.

Using health biomarkers in clinical trials

Clinical trials often rely on episodic and subjective assessment of patients during their visit to the hospital or clinic. The signs and symptoms of a patient when away from the hospital are often unknown, especially in certain neurological conditions, which may cause clinicians to miss critical insights on disease progression or symptoms.

Digital health devices can provide unbiased, quantifiable and continuous real-time data on a patient’s condition from the comfort of their home enabling clinicians to assess the study endpoints and the drug’s efficacy. The biomarkers identified by digital devices can provide novel insights that can be used to develop personalised treatments. Being less invasive, they can also improve recruitment, participation and retention of trial patients.

Digital biomarkers are currently being used in clinical trials in diabetes and heart diseases, while they are also being experimented for use in studies on the central nervous system. Privacy and data storage issues, the need for validation of data, and complex analysis needed to understand the data generated by digital devices are some of the challenges involved in using digital biomarkers in clinical trials.