Decentralized Clinical Trials

Decentralized clinical trials (DCTs) represent a patient-centric approach to conducting studies and trials of new medical treatments, vaccines and devices that reduce the patient burden of the traditional “brick and mortar” study model. Labcorp, a pioneer in DCT, has 20 years of experience using technology to provide remote accessibility for clinical trial participants. This can include remote monitoring of key health metrics, lab tests performed using at-home specimen collection kits, mobile specimen collection services and drug administration, and virtual phone and video visits with study participants. DCTs can remove barriers that may have slowed or prevented studies from being conducted in the past. DCTs also make trial participation a viable option for more people, including those from remote and diverse patient populations that are often underrepresented in clinical trials.

COVID-19, which limited the ability to conduct in-person clinical trials, has been a catalyst for DCT innovation. Our experience combined with enhancements we made to our infrastructure allowed us to meet the additional demand for DCT spurred by the pandemic, resulting in a more than 50% year-over-year increase in our DCT awards.

DCTs Have Been Proven to Reduce Patient Burden and Improve Health Equity During the Pandemic by Offering the Following Benefits:

  • Allowed increased trial populations with expanded geographic reach to participate in clinical trials
  • Reduced transportation issues for patients without access to a car or public transportation; in non-traditional trials, patients often must travel two to three hours to reach their nearest study site
  • Reduced time commitments enable patients to maintain normal day-to-day activities
  • Allowed patients to receive drug delivery at home
  • Reduced barriers for patients with mobility constraints and physical or cognitive impairments
  • Allowed remote health monitoring for quicker contact with study teams

New Technology Drives DCT Innovation and Trial Breakthroughs

Accessibility of DCT Platforms and Solutions

The combination of online screening, remote consent, televisits, and use of virtual investigators and mobile nurses makes it possible to reach more patients across a broader geographic footprint than before. These digital solutions allow study sponsors to enroll more patients in less time and to gather data for continuous monitoring and optimization, making it possible to bring essential therapeutics to market faster.

Wearables and Connected Devices

Wearable and mobile devices provide enhanced ways to objectively gather continuous data regarding patient activity and health. Trial participants can perform self-assessments using equipment, such as heart monitors and pulse oximeters, shipped to their homes with virtual support from researchers. The digitally recorded and transmitted data, including real-time data, enables study sites to detect signals and evaluate patient safety proactively.

Digital Biomarkers

Biomarkers, which traditionally required physical interaction, evaluate a biological process to help understand a person’s health. Digital biomarkers are frequently defined as objective, quantifiable physiological and behavioral data collected and measured by digital devices such as portable, wearable, implantable or digestible sensors. In 2021, Labcorp continued to implement technology to advance its use of digital biomarkers in an effort to make clinical research and care processes more patient-centric, risk-based, efficient, personalized and informative.