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

J 2020

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

HOŘAVOVÁ, Lenka; Kateřina NEBESKÁ; Lenka SOUČKOVÁ; Regina DEMLOVÁ; Petr BABULA et al.

Základní údaje

Originální název

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

Autoři

HOŘAVOVÁ, Lenka; Kateřina NEBESKÁ; Lenka SOUČKOVÁ; Regina DEMLOVÁ a Petr BABULA

Vydání

Therapeutic Innovation & Regulatory Science, Heidelberg, Springer Nature, 2020, 2168-4790

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30104 Pharmacology and pharmacy

Stát vydavatele

Německo

Utajení

není předmětem státního či obchodního tajemství

Odkazy

URL

Impakt faktor

Impact factor: 1.778

Označené pro přenos do RIV

Ano

Kód RIV

RIV/00216224:14110/20:00115854

Organizační jednotka

Lékařská fakulta

Klíčová slova anglicky

Non-commercial Clinical Trials; Paediatric clinical research; Financial sources; International Clinical Trials Registries; Infrastructure

Štítky

14110515, 14110516, rivok

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 4. 4. 2022 13:02, Mgr. Tereza Miškechová

Anotace

V originále

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.

Návaznosti

CZ.02.1.01/0.0/0.0/16_013/0001826, interní kód MU
(Kód CEP: EF16_013/0001826)

Název: CZECRIN_PRO PACIENTY - zavádění inovativních moderních terapií

Investor: Ministerstvo školství, mládeže a tělovýchovy ČR, CZECRIN_PRO PACIENTY - zavádění inovativních moderních terapií, PO 1 Posilování kapacit pro kvalitní výzkum

LM2018128, projekt VaV

Název: Český národní uzel Evropské sítě infrastruktur klinického výzkumu (Akronym: CZECRIN)

Investor: Ministerstvo školství, mládeže a tělovýchovy ČR, Český národní uzel Evropské sítě infrastruktur klinického výzkumu (CZECRIN)

Přiložené soubory

Horavova_et_al-2020-Therapeutic_Innovation___Regulatory_Science.pdf

Požádat o autorskou verzi souboru

Citovat

HOŘAVOVÁ, Lenka; Kateřina NEBESKÁ; Lenka SOUČKOVÁ; Regina DEMLOVÁ a Petr BABULA. 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. Therapeutic Innovation & Regulatory Science. Heidelberg: Springer Nature, 2020, roč. 54, č. 6, s. 1461-1472. ISSN 2168-4790. Dostupné z: https://doi.org/10.1007/s43441-020-00173-9.

@article{1664036,
   author = {Hořavová, Lenka and Nebeská, Kateřina and Součková, Lenka and Demlová, Regina and Babula, Petr},
   article_location = {Heidelberg},
   article_number = {6},
   doi = {https://doi.org/10.1007/s43441-020-00173-9},
   keywords = {Non-commercial Clinical Trials; Paediatric clinical research; Financial sources; International Clinical Trials Registries; Infrastructure},
   language = {eng},
   issn = {2168-4790},
   journal = {Therapeutic Innovation & Regulatory Science},
   title = {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},
   url = {https://rdcu.be/b4GbX},
   volume = {54},
   year = {2020}
}

TY  - JOUR
ID  - 1664036
AU  - Hořavová, Lenka - Nebeská, Kateřina - Součková, Lenka - Demlová, Regina - Babula, Petr
PY  - 2020
TI  - 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
JF  - Therapeutic Innovation & Regulatory Science
VL  - 54
IS  - 6
SP  - 1461-1472
EP  - 1461-1472
PB  - Springer Nature
SN  - 21684790
KW  - Non-commercial Clinical Trials
KW  - Paediatric clinical research
KW  - Financial sources
KW  - International Clinical Trials Registries
KW  - Infrastructure
UR  - https://rdcu.be/b4GbX
L2  - https://rdcu.be/b4GbX
N2  - 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.
ER  -

HOŘAVOVÁ, Lenka; Kateřina NEBESKÁ; Lenka SOUČKOVÁ; Regina DEMLOVÁ a Petr BABULA. 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. \textit{Therapeutic Innovation \&{} Regulatory Science}. Heidelberg: Springer Nature, 2020, roč.~54, č.~6, s.~1461-1472. ISSN~2168-4790. Dostupné z: https://doi.org/10.1007/s43441-020-00173-9.

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