Cargando…

Pediatric Melanoma and Drug Development

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.clin...

Descripción completa

Detalles Bibliográficos
Autores principales: Rose, Klaus, Grant-Kels, Jane M.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5867502/
https://www.ncbi.nlm.nih.gov/pubmed/29558389
http://dx.doi.org/10.3390/children5030043
_version_ 1783308976902897664
author Rose, Klaus
Grant-Kels, Jane M.
author_facet Rose, Klaus
Grant-Kels, Jane M.
author_sort Rose, Klaus
collection PubMed
description 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.
format Online
Article
Text
id pubmed-5867502
institution National Center for Biotechnology Information
language English
publishDate 2018
publisher MDPI
record_format MEDLINE/PubMed
spelling pubmed-58675022018-03-27 Pediatric Melanoma and Drug Development Rose, Klaus Grant-Kels, Jane M. Children (Basel) Opinion 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. MDPI 2018-03-20 /pmc/articles/PMC5867502/ /pubmed/29558389 http://dx.doi.org/10.3390/children5030043 Text en © 2018 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Opinion
Rose, Klaus
Grant-Kels, Jane M.
Pediatric Melanoma and Drug Development
title Pediatric Melanoma and Drug Development
title_full Pediatric Melanoma and Drug Development
title_fullStr Pediatric Melanoma and Drug Development
title_full_unstemmed Pediatric Melanoma and Drug Development
title_short Pediatric Melanoma and Drug Development
title_sort pediatric melanoma and drug development
topic Opinion
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5867502/
https://www.ncbi.nlm.nih.gov/pubmed/29558389
http://dx.doi.org/10.3390/children5030043
work_keys_str_mv AT roseklaus pediatricmelanomaanddrugdevelopment
AT grantkelsjanem pediatricmelanomaanddrugdevelopment