Digital Biomarkers and Endpoints

Digital Biomarkers and Endpoints: Why They Matter in a DCT Setting

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Various data points, including digital biomarkers, are critical in helping researchers assess the efficacy and safety of therapeutics in decentralized clinical trials (DCTs).

With the increased availability and reliability of personal medical devices, consumers and researchers alike have access to a wider range of digital biomarkers than ever before. Devices and apps count steps, track heart rate, assess sleep quantity and quality, and continuously track blood glucose and blood pressure levels, among other biomarkers.

The global market for wearable medical devices is estimated to be $12.1 billion this year, and approximately 30% of smartphone users in the U.S. use at least one health app.

For many interventions under study, the data of daily living gathered via these devices may be as important as the data gathered during routine laboratory check-ins with clinical trial participants. So, it follows that digital biomarkers stand to have a profound impact on — and even enable — the digital transformation of the healthcare industry and DCTs.

Digital biomarkers and endpoints explained

Clinical endpoints characterize how clinical trial participants feel or function. The work of clinical research is aimed at improving morbidity and mortality, and the objective is endpoint data that clearly shows whether interventions are effective and safe.

A biological marker, or biomarker, refers to medical signs (chemical, physical, behavioural or biological in nature) that can be objectively measured. Biomarkers can include pulse rate, blood pressure, cholesterol, blood glucose, activity and more, and researchers must determine how biomarker data correlates with the clinical endpoint(s) they’re studying. In some cases, a biomarker may be viewed as a “surrogate endpoint” in a clinical trial — for example, can we observe the impact of physical activity and sleep on blood glucose.

A number of tools exist to help gather different kinds of data. Consumers can use activity trackers to assess the impact of their diet on their weight and blood pressure levels. Virtual clinical trial participants might ingest a pill that contains a sensor to study acid levels in the GI tract. A person’s smartphone might be part of a sensor system to detect changes in voice to study stress.

Value of remote digital biomarker data capture

The COVID-19 pandemic helped expedite the acceptance of decentralized clinical trials (DCTs). As healthcare resources were needed for diagnosing, studying, and treating COVID-19 — and travel was limited — the number of new clinical trials sharply declined in the early months of the pandemic. Since then, a newfound reliance on and trust of virtual tools across the healthcare industry has enabled an uptick in DCTs.

The benefits of remote data capture go beyond flexibility in a pandemic. When we move research into the DCT setting, we are able to democratize clinical trial access. Across geography, race, income, and social status, clinical participants — armed with digital medical devices — can go about their daily lives, gathering key data relevant to their disease/condition or treatment without effort or inconvenience.

The use of digital medical devices 24/7 means researchers aren’t limited to the data they capture when trial participants visit a clinical site.  Instead they’re gathering real-world, long-term data, which may prove to be more meaningful - offering actionable insights for the development of new medicines and longitudinal care plans for patients.

These digital tools enable real-world data capture and also facilitate remote continuous patient monitoring, which helps ensure safety during a trial. Plus, healthcare providers can use the same technology platforms to monitor patients in real time and intervene as needed. As telehealth becomes more widely accepted and wearable medical devices more reliable, consumers will also experience a change in their healthcare access and experience, as they are empowered to monitor and manage their own health in new ways.

Challenges of identifying and validating data

Even with all the positives of digital biomarkers and the tools used to collect this data, there remain challenges. As with any clinical trial, regulatory issues and compliance can be a burden. Plus, it can be difficult to ensure consistency of the data capture as well as data standardization.

Too much data – continuous data collection may lead to too much “noise” which masks relevant efficacy and/or safety signals or risks

Digital clinical trials spanning geographies also may be impacted by uneven access to medical devices and to the internet itself, and data security certainly presents a unique challenge globally for DCTs.

Benefits of a DCT platform in collecting digital biomarker data

Researchers are responsible for developing a clinical trial protocol that ensures data integrity and standardization and that takes into account the end-user experience.  

This is where utilizing an established Software as a Medical Device (SaMD) platform is beneficial. These platforms are used in clinical settings to help providers diagnose and treat patients as well as in the management of DCTs.

Medable offers clinical trial software solutions to help you design trials according to your data and treatment goals, needs, and desired outcomes. Partnering with Medable provides:

  • A flexible DCT platform
  • An intuitive experience that’s both human- and data-centered, enabling efficient workflows
  • An app that fits within patients’ daily lives

With DCTs rising in popularity and growing in scope, a trusted platform can help ensure all data is collected consistently and analyzed with integrity.

​​See how our platform makes decentralized clinical trials more efficient. Request a demo today.