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Comment & Response |

Too Few Medicines for Children With Cancer—Reply

Peter C. Adamson, MD1
[+] Author Affiliations
1Children’s Oncology Group, The Children’s Hospital of Philadelphia, Philadelphia, Pennsylvania
JAMA Pediatr. 2014;168(6):583-584. doi:10.1001/jamapediatrics.2014.18.
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In Reply I thank Herold et al for their thoughtful letter and their commitment to improving the drug development process for children with cancer. As a leader of an international collaborative childhood cancer research organization, in my experience—contrary to their conclusion—the process surrounding pediatric investigation plan approvals is delaying the onset of a number of pediatric phase 1 cancer trials. While it is fully appreciated that completed early-phase trials have been accepted in the past by the European Medicines Agency, it is likely the effect of regulatory uncertainty1 that leads a number of biopharmaceutical industry sponsors to delay the onset of pediatric clinical research until a pediatric investigation plan is approved.

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June 1, 2014
Ralf Herold, MD, PhD; Agnès Saint-Raymond, MD; Koenraad Norga, MD, PhD
1European Medicines Agency, London, United Kingdom
2Department of Paediatric Oncology, Antwerp University Hospital (UZA), Edegem, Belgium3Department of Medicine and Health Sciences, Antwerp University, Wilrijk, Belgium
JAMA Pediatr. 2014;168(6):583. doi:10.1001/jamapediatrics.2014.15.
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