A decentralized clinical trial (DCT) is a type of clinical trial where some or all trial-related activities occur outside of traditional clinical sites, such as hospitals or research centers. Instead, these trials use digital health technologies, home visits, and local healthcare providers to collect data from participants in their own homes or nearby facilities.
Advantages of DCTs include:
- Increased patient accessibility: Participants can join from various geographic locations, increasing recruitment and retention rates.
- Improved patient experience: Reduced travel and onsite visits enhance convenience and adherence.
- Cost efficiency: Potentially lower costs due to reduced need for physical infrastructure.
- Data quality and real-time monitoring: Use of digital tools can improve data accuracy and allow for continuous monitoring.
- Real-world data collection: Since participants remain in their usual environment, the data collected may better reflect real-life conditions
However, DCTs also present several challenges:
- Regulatory and data integrity concerns: Ensuring data reliability and meeting regulatory standards can be challenging, especially as different countries have different regulations on remote data collection
- Technological barriers: Participants must use digital tools like mobile apps or wearable devices, which may be challenging for older or less tech-savvy individuals.
- Increased costs in some areas: Services like home nursing can be expensive.
- Complex logistics: Coordinating remote activities and managing diverse data sources can be complex.
Overall, DCTs offer significant benefits but also present unique challenges that must be carefully managed to ensure trial success.