Module232025

12/05/2025

Clinical trial topics Discussed during Paediatric Cluster Meetings

Between August 2007 and March 2019: Information exchanged on 517 products, with 172 discussions on general topics*

Between 2014 and 2017, convergence was achieved for 73% of the issues discussed

* US Food & Drug Administration. International Collaboration / Pediatric Cluster. 2020. Available at https://www.fda.gov/science-research/pediatrics/international-collaboration-pediatric-cluster

The Organisation for Professionals in Regulatory Affairs

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M Dehlinger-Kremer, 14 May 2025

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Drug indications discussed during paediatric cluster product discussions 2020 Paediatric Cluster Call Topics

57 specific products were discussed

Majority in oncology

Illustrates importance and the need for global paediatric development plans

Source: Presentation Lynn Yao 2021 at ICON’s World Children’s Day

The Organisation for Professionals in Regulatory Affairs

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M Dehlinger-Kremer, 14 May 2025

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