COVID-19 Clinical Trial Disruptions: A Real-World Test Of De-Centralized Techniques

US FDA asks oncology drug sponsors for information on the impact of modifications to clinical trials during the pandemic – with close attention to remote monitoring and data collection.

clicks on a digital tablet on background. Research and development decentralization software concept

The changes to clinical trial conduct necessitated by the COVID-19 outbreak is providing a “natural experiment” to test different techniques to run de-centralized clinical trials, representatives of the US Food & Drug Administration suggested during a 13-14 July meeting on the evolution of digital health systems in oncology.

“This pandemic in many ways functions as a natural experiment on home and community-based cancer innovation,” deputy commissioner for medical/scientific affairs Anand Shah observed

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