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

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...

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