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Open AccessOpinion
Children 2018, 5(3), 43; https://doi.org/10.3390/children5030043

Pediatric Melanoma and Drug Development

1
klausrose Consulting, Pediatric Drug Development & More, 4125 Riehen, Switzerland
2
Department of Dermatology, University of Connecticut Health Center, Farmington, CT 06030, USA
*
Author to whom correspondence should be addressed.
Received: 19 February 2018 / Revised: 14 March 2018 / Accepted: 14 March 2018 / Published: 20 March 2018
(This article belongs to the Section Oncology and Hematology)
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Abstract

Importance—Pediatric melanoma occurs, albeit rarely. Should patients be treated by today’s medical standards, or be subjected to medically unnecessary clinical studies? Observations—We identified international, industry-sponsored pediatric melanoma studies triggered by regulatory demands in www.clinicaltrials.gov and further pediatric melanoma studies demanded by European Union pediatric investigation plans. We retrieved related regulatory documents from the internet. We analyzed these studies for rationale and medical beneficence on the basis of physiology, pediatric clinical pharmacology and rationale. Regulatory authorities define children by chronological age, not physiologically. Newborns’ organs are immature but they develop and mature rapidly. Separate proof of efficacy in underage patients is justified formally/regulatorily but lacks medical sense. Children—especially post-puberty—and adults vis-a-vis medications are physiologically very similar. Two adolescent melanoma studies were terminated in 2016 because of waning recruitment, while five studies in pediatric melanoma and other solid tumors, triggered by European Union pediatric investigation plans, continue recruiting worldwide. Conclusions and Relevance—Regulatory-demanded pediatric melanoma studies are medically superfluous. Melanoma patients of all ages should be treated with effective combination treatment. Babies need special attention. Children need dose-finding and pharmacokinetic studies but adolescents metabolize and respond to drugs similarly to adults. Institutional Review Boards/ethics committees should suspend ongoing questionable pediatric melanoma studies and reject newly submitted questionable studies. View Full-Text
Keywords: pediatric drug development; Pediatric Investigation Plan (PIP); pediatric pharmaceutical legislation; EU pediatric regulation; pediatric clinical pharmacology; developmental pharmacology; pediatric laws; pediatric clinical studies pediatric drug development; Pediatric Investigation Plan (PIP); pediatric pharmaceutical legislation; EU pediatric regulation; pediatric clinical pharmacology; developmental pharmacology; pediatric laws; pediatric clinical studies
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited (CC BY 4.0).
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Rose, K.; Grant-Kels, J.M. Pediatric Melanoma and Drug Development. Children 2018, 5, 43.

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