What are Decentralized Clinical Trials (DCTs)?

Decentralized Clinical Trials (DCTs) are clinical studies that leverage technology to move trial activities out of traditional clinical settings and closer to participants, often directly to their homes or local healthcare providers. These trials use tools such as telemedicine, wearable devices, mobile apps, and home visits to collect data and monitor patients remotely. DCTs can be fully remote, where all interactions occur outside of centralized research sites, or hybrid, combining elements of both remote and in-person assessments.

What is the significance of Decentralized Clinical Trials?

The significance of DCTs lies in their potential to improve patient recruitment and retention by offering greater convenience and accessibility. They allow participants to engage in trials without the need for frequent travel to distant clinical sites, which can be a barrier, especially for those with mobility issues or those living in remote areas. DCTs also make it easier to include a more diverse patient population, as the trials can reach participants beyond the immediate geographical area of a clinical site.

Moreover, DCTs can lead to faster data collection and more real-time insights. The technology-driven approach, including the use of wearable health devices, allows for continuous monitoring and immediate reporting of adverse events and outcomes. This model also reduces trial costs by eliminating the need for infrastructure at central sites and minimizing logistical expenses.

What are the challenges associated with Decentralized Clinical Trials?

Despite their advantages, DCTs are associated with several challenges. One major hurdle is ensuring that all participants have access to the necessary technology, such as mobile devices or stable internet connections, which is not universally available. There is also a learning curve associated with technology adoption, as some patients may not be comfortable using apps or devices.

Data security is another concern, as the collection of sensitive health information through digital tools increases the risk of cyberattacks and privacy breaches. Ensuring compliance with global regulatory standards such as GDPR, HIPAA, and FDA guidelines is crucial for maintaining patient confidentiality and trust.

Additionally, managing the vast amounts of data collected from various digital health technologies can be complex. Sponsors must have robust systems in place to track and analyze data from diverse sources to ensure the integrity of the trial.

DDReg’s Capabilities

• Authoring, compiling, reviewing, and submitting clinical trial application packages.
• e-submission of clinical trial applications.
• Responding to queries from agencies regarding clinical trial application submissions.
• Translation services for clinical trial documentation.
• Post IND/CTA Submission Regulatory Activities.
• Support for the US FDA Diversity Plan includes collating available information for planned studies and Racial and Ethnic Minority (REM) subgroups.