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US FDA Oncology Center Wants Trial Datasets Flagged As Remote Or In-Person Assessments

 
• By Sue Sutter

Agency wants to use pandemic-interrupted clinical trials to gauge how decentralized approaches impacted study integrity and to inform prospective use of such designs post-COVID.

Flags red and green
Special flags for 'remote' and 'trial site' assessments in cancer trial datasets will inform the use of decentralized approaches going forward. • Source: Shutterstock

The US Food and Drug Administration's oncology center intends to leverage datasets from cancer studies interrupted by the COVID-19 pandemic to advance the use of decentralized clinical trial approaches.

The Oncology Center of Excellence is requesting that applicants submitting data in support of new drug applications or biologic license applications voluntarily add flags to distinguish between “REMOTE” and “TRIAL...

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