The Current Status of European and National Financial Sources for Clinical Research and Their Impact on Paediatric Non-commercial Clinical Trials: A Case Study of the Czech Republic

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00209805%3A_____%2F20%3A00078416" target="_blank" >RIV/00209805:_____/20:00078416 - isvavai.cz</a>

Nalezeny alternativní kódy

RIV/00159816:_____/20:00073469 RIV/00216224:14110/20:00115854

Výsledek na webu

<a href="https://link.springer.com/article/10.1007/s43441-020-00173-9" target="_blank" >https://link.springer.com/article/10.1007/s43441-020-00173-9</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1007/s43441-020-00173-9" target="_blank" >10.1007/s43441-020-00173-9</a>

Jazyk výsledku

angličtina

Název v původním jazyce

The Current Status of European and National Financial Sources for Clinical Research and Their Impact on Paediatric Non-commercial Clinical Trials: A Case Study of the Czech Republic

Popis výsledku v původním jazyce

Introduction: Paediatric non-commercial interventional clinical trials (NICTs) are crucial for healthcare provision. In spite of the fact that current regulations and initiatives try to enhance the quantity and quality of paediatric NICTs, there are still shortcomings that need to be addressed in order to accelerate the conduct of relevant clinical trials in children. To improve the current landscape of paediatric clinical research, it is necessary to identify and analyse the main trends and shortcomings, along with their impact on national performance in paediatric NICTs and this is the aim of this work. Method: A retrospective systematic search of paediatric NICTs was performed on four international clinical trials registries. Entries were filtered by date from 01/01/2004 to 31/12/2017. Each identified paediatric NICT was screened and analysed for sponsors, funders, type of intervention, therapeutic area, design characteristics and associated publications. Results: The search identified 439 unique NICTs. When stratifying the trials by enrolment ages, 86 trials were found involving the paediatric population. Most trials investigated the use of medicinal products and were focused on cancer or cardiovascular diseases. The most common sources of the funding were non-profit organizations. Furthermore, from the total number of completed trials, only half of them already published their results. Conclusion: The main shortcomings-specifically, ethical, methodological and, in particular, economic obstacles were identified. There is a continual need for greater support and collaboration between all major stakeholders including health policymakers, grant agencies, research institutions, pharmaceutical industries and healthcare providers at the national and international level.

Název v anglickém jazyce

The Current Status of European and National Financial Sources for Clinical Research and Their Impact on Paediatric Non-commercial Clinical Trials: A Case Study of the Czech Republic

Popis výsledku anglicky

Introduction: Paediatric non-commercial interventional clinical trials (NICTs) are crucial for healthcare provision. In spite of the fact that current regulations and initiatives try to enhance the quantity and quality of paediatric NICTs, there are still shortcomings that need to be addressed in order to accelerate the conduct of relevant clinical trials in children. To improve the current landscape of paediatric clinical research, it is necessary to identify and analyse the main trends and shortcomings, along with their impact on national performance in paediatric NICTs and this is the aim of this work. Method: A retrospective systematic search of paediatric NICTs was performed on four international clinical trials registries. Entries were filtered by date from 01/01/2004 to 31/12/2017. Each identified paediatric NICT was screened and analysed for sponsors, funders, type of intervention, therapeutic area, design characteristics and associated publications. Results: The search identified 439 unique NICTs. When stratifying the trials by enrolment ages, 86 trials were found involving the paediatric population. Most trials investigated the use of medicinal products and were focused on cancer or cardiovascular diseases. The most common sources of the funding were non-profit organizations. Furthermore, from the total number of completed trials, only half of them already published their results. Conclusion: The main shortcomings-specifically, ethical, methodological and, in particular, economic obstacles were identified. There is a continual need for greater support and collaboration between all major stakeholders including health policymakers, grant agencies, research institutions, pharmaceutical industries and healthcare providers at the national and international level.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30104 - Pharmacology and pharmacy

Projekt

Výsledek vznikl pri realizaci vícero projektů. Více informací v záložce Projekty.

Návaznosti

—

Rok uplatnění

2020

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

Therapeutic innovation &amp; regulatory science

ISSN

2168-4790

e-ISSN

—

Svazek periodika

54

Číslo periodika v rámci svazku

6

Stát vydavatele periodika

CH - Švýcarská konfederace

Počet stran výsledku

12

Strana od-do

1461-1472

Kód UT WoS článku

000538213900001

EID výsledku v databázi Scopus

2-s2.0-85086095982