In a JAMA Viewpoint published online this week, coauthors Adrian Hernandez and Chris Lindsell caution that, although the use of decentralized trials creates meaningful efficiencies, there are major threats to the validity of these trials not captured by traditional monitoring and oversight practices.
In a decentralized clinical trial, some or all of the trial-related activities take place at locations other than the trial site, which can result in decrease in travel, time, and burden for patients. However, these trials can pose risks related to:
- verifying participant identity
- delivering the investigational product to the participant
- minimizing lags between participants’ data entry and identification of the need for action to ensure safety and compliance, including adherence to treatment and outcome measurements
“With these risks to integrity forefront, and consistent with the principles of using decentralized elements and risk-proportionate monitoring, we propose [decentralized trials] frame their monitoring and oversight to ensure the right patient receives the right intervention, contributes the right data, and that the right response occurs for adverse events or noncompliance,” the authors wrote.
This work was based on the February 23, 2024, session of the NIH Pragmatic Trials Collaboratory’s Rethinking Clinical Trials Grand Rounds webinar, “Virtual Vigilance: Monitoring of Decentralized Clinical Trials.”