Seven years after the launch of the European Paediatric Medicine Regulation, limited progress in paediatric oncology drug development remains a major concern amongst stakeholders - academics, industry, regulatory authorities, parents, patients and caregivers. Restricted increases in early phase paediatric oncology trials, legal requirements and regulatory pressure to propose early Paediatric Investigation Plans (PIPs), missed opportunities to explore new drugs potentially relevant for paediatric malignancies, lack of innovative trial designs and no new incentives to develop drugs against specific paediatric targets are some unmet needs.

Authors: G. Vassala, R.Rousseaub, P. Blancc, L. Morenod, G. Bodee, S. Schwochf, M. Schrappeg, J. Skolnikh, L. Bergmani, M.B. Bradley-Garelikj,V.Sahak, A. Pearsonl, H. Zwierzinam

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