From clinical research to approvals: the value of academic–industry collaboration

A study by Macy and colleagues, published in the Journal of the National Cancer Institute on 26 March 2026, examined FDA paediatric oncology approvals between 2000 and 2024.

Of the 53 indication approvals included in the analysis, covering 37 drugs or biologics, 25 assets (47%) were supported by Children’s Oncology Group (CGO) trial data. These approvals drew on 21 COG-associated studies across different partnership models.

The findings demonstrate the contribution of academic networks and public–private collaboration to generating clinical evidence for regulatory decisions. 

For ITCC-P4, the study reinforces the value of connecting molecular evidence, preclinical evaluation and clinical development expertise. We support developers from early scientific discussions and preclinical development planning through to study design, execution and interpretation. Together with our scientific experts and CRO partners, we help identify evidence gaps, select appropriate experimental approaches and generate data to inform paediatric development strategies and discussions with regulatory authorities.

Read the publication details and article reference.

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