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Pediatric Cancer Trials: US FDA Panel To Weigh Use Of Real-World Data, Patient-Reported Outcomes

 
• By Sue Sutter

Advisory committee will discuss ways to encourage inclusion of the Pediatric PRO-CTCAE tool in cancer trials on 11 May, followed the next day by a discussion on real-world data sources that could inform the efficacy and long-term safety of pediatric cancer treatments.

Girl with diary
An FDA panel will discuss the utility of patient self-reporting in pediatric cancer trials. • Source: Alamy

A US Food and Drug Administration advisory committee will consider the use of real-world data sources to construct external controls as part of two-day meeting on pediatric oncology drug development issues.

On 12 May, the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee will discuss real-world evidence for regulatory use in pediatrics, real-world data resources, and RWD and RWE...

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