Review article
https://doi.org/10.21860/medflum2019_227129
Review of incentives for pediatric drug development and of the number of phase III clinical trials in selected countries
Erna Knežević
; Katedra za farmaciju, Sveučilište u Splitu, Medicinski fakultet, Split, Hrvatska
Doris Rušić
; Katedra za farmaciju, Sveučilište u Splitu, Medicinski fakultet, Split, Hrvatska
Josipa Bukić
; Katedra za farmaciju, Sveučilište u Splitu, Medicinski fakultet, Split, Hrvatska
Joško Božić
; Katedra za patofiziologiju, Sveučilište u Splitu, Medicinski fakultet, Split, Hrvatska
Ana Šešelja Perišin
orcid.org/0000-0001-7927-5311
; Katedra za farmaciju, Sveučilište u Splitu, Medicinski fakultet, Split, Hrvatska
Dario Leskur
; Katedra za farmaciju, Sveučilište u Splitu, Medicinski fakultet, Split, Hrvatska
Darko Modun
orcid.org/0000-0001-9508-9383
; Katedra za farmaciju, Sveučilište u Splitu, Medicinski fakultet, Split, Hrvatska
Siniša Tomić
orcid.org/0000-0002-3500-9940
; Katedra za farmaciju, Sveučilište u Splitu, Medicinski fakultet, Split, Hrvatska; Agencija za lijekove i medicinske proizvode, Zagreb, Hrvatska
Abstract
It is estimated that more than 50% of medicines used in pediatric in the EU have never been tested in that population. The aim of this article was to review the laws and incentives for clinical trials in the pediatric population and compare them to the number of phase III clinical trials in the pediatric population funded by the industry as well as their proportion in the total number of clinical trials of phase III over the last ten years. A review of clinical trials in a pediatric population and legal frameworks that regulates the same for eighteen states of different development and the EU has been made. For the countries included in the study, the number of pediatric clinical trials of phase III funded by the industry and their proportion in the total number of clinical trials of phase III funded by the industry registered in the clinicaltrials.gov database during the period from 2008 to 2017 was reviewed. The most commonly used incentives for the development of pediatric drugs were SPCs or years of patent protection. EU, the US and Switzerland have developed legislation with a system of obligations to implement them. Developed states have strictly regulated legislation and formed incentives for pediatric clinical trials, but research is often conducted in underdeveloped states for simplicity and price. In the EU, Japan and Switzerland, an increasing trend in the number of pediatric clinical trials have been observed after introducing initiatives and incentives to encourage them. Inequalities in the degree of regulation of the obligation to carry out clinical trials in pediatric population among states have been established. There was no link between the number or the proportion of pediatric patients in the total number of phase III clinical trials and the degree of regulation of the obligations and incentives for pediatric clinical trials in a particular country.
Keywords
clinical trial, phase III; Legislation, pharmacy; pediatric drugs
Hrčak ID:
227129
URI
Publication date:
1.12.2019.
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