PMID- 32504401
OWN - NLM
STAT- MEDLINE
DCOM- 20210603
LR  - 20240330
IS  - 2168-4804 (Electronic)
IS  - 2168-4790 (Print)
IS  - 2168-4790 (Linking)
VI  - 54
IP  - 6
DP  - 2020 Nov
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.
PG  - 1461-1472
LID - 10.1007/s43441-020-00173-9 [doi]
AB  - 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.
FAU - Horavova, L
AU  - Horavova L
AUID- ORCID: 0000-0002-5899-7742
AD  - Department of Applied Pharmacy, Faculty of Pharmacy, University of Veterinary and 
      Pharmaceutical Sciences Brno, Brno, Czech Republic. lhoravova@cvbf.net.
AD  - Department of Pharmacology, Faculty of Medicine, Masaryk University, Kamenice 
      753/5, 625 00, Brno, Czech Republic. lhoravova@cvbf.net.
FAU - Nebeska, K
AU  - Nebeska K
AD  - European Clinical Research Infrastructure Network (ECRIN), Paris, France.
AD  - Department of Pharmacology, Faculty of Medicine, Masaryk University, Kamenice 
      753/5, 625 00, Brno, Czech Republic.
FAU - Souckova, L
AU  - Souckova L
AD  - European Clinical Research Infrastructure Network (ECRIN), Paris, France.
AD  - Department of Pharmacology, Faculty of Medicine, Masaryk University, Kamenice 
      753/5, 625 00, Brno, Czech Republic.
AD  - University Hospital St. Anne's Brno - International Clinical Research Center, 
      Brno, Czech Republic.
FAU - Demlova, R
AU  - Demlova R
AD  - European Clinical Research Infrastructure Network (ECRIN), Paris, France.
AD  - Department of Pharmacology, Faculty of Medicine, Masaryk University, Kamenice 
      753/5, 625 00, Brno, Czech Republic.
AD  - University Hospital St. Anne's Brno - International Clinical Research Center, 
      Brno, Czech Republic.
AD  - Department of Clinical Trials, Masaryk Memorial Cancer Institute Brno, Brno, 
      Czech Republic.
FAU - Babula, P
AU  - Babula P
AD  - Department of Applied Pharmacy, Faculty of Pharmacy, University of Veterinary and 
      Pharmaceutical Sciences Brno, Brno, Czech Republic.
AD  - Department of Physiology, Faculty of Medicine, Masaryk University, Brno, Czech 
      Republic.
LA  - eng
GR  - CZECRIN (Identification code LM2015090)/Ministerstvo Skolstvi, Mladeze a 
      Telovychovy/
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20200605
PL  - Switzerland
TA  - Ther Innov Regul Sci
JT  - Therapeutic innovation & regulatory science
JID - 101597411
SB  - IM
MH  - Adolescent
MH  - Aged, 80 and over
MH  - Child
MH  - *Clinical Trials as Topic
MH  - Czech Republic
MH  - Drug Industry
MH  - *Health Personnel
MH  - Humans
MH  - Infant
MH  - Infant, Newborn
MH  - Neoplasms
MH  - Retrospective Studies
PMC - PMC7704485
OTO - NOTNLM
OT  - Financial sources
OT  - Infrastructure
OT  - International Clinical Trials Registries
OT  - Non-commercial Clinical Trials
OT  - Paediatric clinical research
COIS- All named authors have no conflict of interest to declare.
EDAT- 2020/06/07 06:00
MHDA- 2021/06/04 06:00
PMCR- 2020/06/05
CRDT- 2020/06/07 06:00
PHST- 2020/03/18 00:00 [received]
PHST- 2020/05/28 00:00 [accepted]
PHST- 2020/06/07 06:00 [pubmed]
PHST- 2021/06/04 06:00 [medline]
PHST- 2020/06/07 06:00 [entrez]
PHST- 2020/06/05 00:00 [pmc-release]
AID - 10.1007/s43441-020-00173-9 [pii]
AID - 173 [pii]
AID - 10.1007/s43441-020-00173-9 [doi]
PST - ppublish
SO  - Ther Innov Regul Sci. 2020 Nov;54(6):1461-1472. doi: 10.1007/s43441-020-00173-9. 
      Epub 2020 Jun 5.