Oversight & Clinical Management

Site staff readiness and training

In conventional trials, sites traditionally serve as central locations for patient recruitment, monitoring and data collection, and regulatory compliance. In a DCT these traditional roles change, shifting some trial activities away from sites to remote settings. The perspective of sites is vital for the successful implementation of DCT elements in practice. However, there remains a significant knowledge gap regarding how DCTs impact clinical sites operationally, technologically, and attitudinally.

Recommendations

Evaluate the applicability of the fees. When tasks are performed by third-party service providers, the fees can be omitted from site fees, such as using central pharmacy for drug dispensing and shipment. However, do calculate time for sites to request these activities and file necessary documents related to these tasks. Inevitably, the increased use of devices and tasks performed by participants, rather than site personnel, requires more time for training and troubleshooting when devices malfunction. 

Evaluate the site’s previous exposure to decentralised elements, such as remote study drug data monitoring and trial applications. We don’t recommend to only select experienced sites, but sites that have less experience with decentralised elements require more time for contracting, set-up and training.

While it’s the sponsor’s responsibility to select and/or design user-friendly systems and adequately train the site to use these systems, it is inevitable that site personnel might need necessary digital skills to manage DCT elements effectively. 

Address potential delays in site contracting by clarifying the delegation of tasks and data processing responsibilities due to DCT elements early in the process. DCTs often involve multiple third-party service providers that carry out parts of the trial tasks, these should be clarified before contract negotiations and contracting templates should be adapted to include DCT elements.

How Trials@Home reached these recommendations

The set-up, conduct, and evaluation of the RADIAL trial enabled us to gather valuable insights from site personnel through quantitative questionnaires administered during the trial and qualitative interviews conducted afterwards. Additionally, we incorporated experiences from both the sponsor and CRO perspectives to provide a more comprehensive understanding.

Further reading

Publications

Selecting and Preparing Clinical Sites for the Successful Conduct of Decentralized Clinical Trial Activities–Findings From the Trials@Home RADIAL Proof-of-Concept Trial

Lipinska, et al
Clinical Pharmacology & Therapeutics
2025
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