Evaluating the True Impacts from Decentralized Trials: Do they Reduce or Increase Burden?

Synopsis

As the healthcare landscape continues to evolve, decentralization promises to reduce burden on both healthcare facilities and patients alike. However, there is also a danger that new challenges will emerge, potentially increasing burden in new areas. Therefore, it is critical to consider the quality and consistency of data collected across multiple sites, the different regulatory requirements, and the level of training and support required for staff and participants.

This discussion will explore the implications and opportunities of decentralized trials to determine whether they truly present the best ROI.

• Site Accessibility: How does the decentralization of clinical trials impact the accessibility of research sites for patients?
• Are decentralized trials facilitating or hindering patient recruitment efforts compared to traditional centralized or hybrid trials?
• Which group of stakeholders possesses the most potential to broaden acceptance of decentralized trials? Sponors/Sites/Patients/Tech vendors?
• Patient Engagement: How does the DCT’s influence patient engagement and retention throughout the study?
• Data Quality, Accuracy and Standardization: What measures are in place to ensure data quality and integrity in decentralized trials, and how does this affect the
overall burden on patients and sites?
• Have Health Authorities provided enough guidance on the conduct of decentralized trials?