Decentralized clinical trials (DCTs), while offering efficiencies by conducting trial activities outside traditional sites, pose significant risks to data integrity and patient safety that require enhanced virtual monitoring, according to a JAMA commentary by Adrian Hernandez and Chris Lindsell.
Risks to Trial Validity
The shift to DCTs, designed to reduce patient burden and increase accessibility, introduces challenges in several key areas. These include:
- Participant Identity Verification: Ensuring the correct individuals are participating in the trial when activities occur remotely.
- Investigational Product Delivery: Guaranteeing that the investigational product reaches the intended participant and is stored and administered correctly.
- Data Lag and Response Times: Minimizing delays between participant data entry and the identification of necessary actions to ensure safety, compliance, and adherence to treatment and outcome measurements.
Proposed Monitoring Framework
To address these risks, the authors propose a monitoring framework focused on ensuring:
- The right patient receives the right intervention.
- The right data is contributed accurately and reliably.
- The right response is initiated promptly for adverse events or noncompliance.
This framework aligns with the principles of risk-proportionate monitoring, tailoring oversight strategies to the specific challenges presented by decentralized elements.
Implications for Clinical Trial Design
The commentary underscores the need for vigilance in adapting monitoring practices to the decentralized model. Traditional monitoring approaches may not adequately capture the nuances of remote trial activities, potentially compromising data quality and patient safety. By focusing on virtual vigilance and risk-proportionate strategies, researchers can leverage the benefits of DCTs while maintaining the integrity of clinical trial data.
