How digital
biomarkers and
connected devices
are transforming
clinical trials

Digital healthcare has a role to play in making healthcare more accessible to patients now more than ever before. One of the innovative ways healthcare professionals, researchers and patients are embracing digital healthcare is by creating opportunities to enhance clinical trial participation and information sharing using digital biomarkers.

Clinical trials test the safety and efficacy of medical treatments, therapies and devices. Yet, despite the importance of this process to modern healthcare, clinical trial participation is low—participation rates in trials have been estimated to be somewhere between 3% and 8% of potential participants—and often unrepresentative.

These participation challenges have real-world consequences. Approximately 20% of cancer clinical trials fail because of insufficient patient enrollment. Meanwhile, clinical trials without appropriately representative participants can miss the opportunity to assess potential adverse side effects in relevant subsets of the population, such as racial/ethnic minority groups. Location, travel costs, medical mistrust, strict eligibility criteria and scheduling constraints are among the barriers to effective participation in clinical trials.

Remote monitoring of patients using biomarker tracking is one way to help overcome some of these barriers to clinical trial participation. A review by pharmaceutical company AstraZeneca found 70% of trial data could be collected remotely. Remote patient monitoring also has other benefits, according to the U.S. government, including reducing the risk of exposure to infection and illnesses, lower rates of hospitalizations and better management of chronic conditions.

Digital biomarkers are data obtained by digital devices that can help produce actionable insights into the biological state of individuals. These digital devices are among the Internet of Medical Things (IoMT) and applications that, among other uses, help connect patients to their healthcare providers remotely, including for digital clinical trials. The underlying technologies, such as a high-performing network that connects to sensors in the relevant devices, are similar to traditional IoT solutions.

Information is collected using devices that people wear, have implanted, and, in some cases, digest. Some of the tools that assist with biomarker tracking include:

• Wearables—which monitor activity, sleep, heart rate, walking steps, and workouts
• Blood pressure monitor—which calculates a person's heart rate and blood flow
• Electrocardiogram (ECG)—which evaluates heart health by measuring electrical activity
• Glucometer—which measures blood sugar
• Keyboards—which can be assessed to measure keystroke patterns and indicate a change in a person's mobility or brain function

These devices use algorithms to process raw data and turn this data into health-related metrics using technology on smartwatches, other wearables, and smartphones, which can be transferred to a patient's electronic health record. 

Research scientists design clinical trials to test the efficacy and safety of new therapies, manage symptoms of diseases and treatments, and optimally prevent diseases. Researchers need data from a lot of people to make a definitive conclusion about efficacy and safety, and digital biomarker tracking creates opportunities for the collection of more data by:

• Improving the patient experience. The adoption of digital biomarkers may help remove some of the impediments to participating in a trial for patients, such as needing to get time off work/school, travel costs, and unwillingness to risk infection or other diseases (for example, some patients may be unwilling to attend a medical facility due to a perceived higher risk of contracting COVID-19).
• Assisting recruitment. Digital biomarker tracking makes it easier for researchers to identify and contact candidates who meet relevant criteria for trial participation.
• Improving data capture. Passively gathering biometrics from always-on IoMT devices can help address issues of incomplete data, which can cause up to 30% of participants to be excluded from a clinical trial. Providing real-time data also allows research personnel to address any issues promptly by alerting them earlier.
• Enhancing data analysis. This can improve decision-making, including making product or trial design adjustments prior to pre-market and commercial claims and approvals. By leveraging 4G and 5G's data transfer speeds, artificial intelligence (AI) and machine learning, and cloud storage, researchers can share information across different healthcare systems and take advantage of big data analytics to develop new algorithms and prediction models and improve the quality of diagnosis and prophylaxis.

A Forbes article highlighted the cost savings to trial organizers as well, citing a huge bill—clinical trials cost up to $8 million per day. Phase III studies for new drugs approved by the FDA cost a median of $41,117 per patient. This cost could be brought down by tracking patient adherence to medicine from their home using "smart dosing" technology. These technologies range from "smart packaging" that sends the information to the healthcare provider to ingestibles that allow patients to track health information through saliva or urine.