A paediatrician’s guide to Clinical Trials Units
File(s)Arch Dis Child Educ Pract Ed-2016-Gale-265-7.pdf (701.63 KB)
Published version
Author(s)
Gale, CRK
Juszczak, E
Type
Journal Article
Abstract
A clinical trial is a research study that prospectively assigns health-related interventions to people (or groups) typically using randomisation to evaluate the effects on health outcomes. Well-designed, suitably powered, randomised, trials provide the most reliable evidence about the effectiveness (or not) of interventions and should underpin medical practice. Unfortunately, within paediatrics, many common interventions have not been subjected to such rigorous evaluation,1 ,2 leading to variation in both treatments3 ,4 and outcomes (http://www.rightcare.nhs.uk/index.php/atlas/children-and-young-adults/).
Many more high-quality clinical trials are needed before paediatric care is robustly evidence based. Healthcare professionals are ideally placed to inform such trials, but one factor that limits their involvement is the complexity involved: the processes and requirements for trials of investigational medicinal products are illustrated on the clinical trials route map (http://www.ct-toolkit.ac.uk/routemap).
There has been a significant investment in clinical trials research infrastructure over the last decade recognising this complexity. The UK Clinical Research Collaboration Registered Clinical Trials Units (CTU) Network is part of this infrastructure and oversees the registration of CTUs. Registered CTUs need to demonstrate track record, a multidisciplinary team, robust quality assurance systems, statistical input and secure information technology. CTUs exist to help healthcare professionals navigate this complex landscape and assist in developing clinical questions into well-designed studies.
Many more high-quality clinical trials are needed before paediatric care is robustly evidence based. Healthcare professionals are ideally placed to inform such trials, but one factor that limits their involvement is the complexity involved: the processes and requirements for trials of investigational medicinal products are illustrated on the clinical trials route map (http://www.ct-toolkit.ac.uk/routemap).
There has been a significant investment in clinical trials research infrastructure over the last decade recognising this complexity. The UK Clinical Research Collaboration Registered Clinical Trials Units (CTU) Network is part of this infrastructure and oversees the registration of CTUs. Registered CTUs need to demonstrate track record, a multidisciplinary team, robust quality assurance systems, statistical input and secure information technology. CTUs exist to help healthcare professionals navigate this complex landscape and assist in developing clinical questions into well-designed studies.
Date Issued
2016-06-09
Date Acceptance
2016-03-23
Citation
Archives of Disease in Childhood-Education and Practice Edition, 2016, 101, pp.265-267
ISSN
1743-0593
Publisher
BMJ Publishing Group
Start Page
265
End Page
267
Journal / Book Title
Archives of Disease in Childhood-Education and Practice Edition
Volume
101
Copyright Statement
This is an Open Access article distributed in
accordance with the terms of the Creative Commons
Attribution (CC BY 4.0) license, which permits others to
distribute, remix, adapt and build upon this work, for
commercial use, provided the original work is properly cited.
See: http://creativecommons.org/licenses/by/4.0/
accordance with the terms of the Creative Commons
Attribution (CC BY 4.0) license, which permits others to
distribute, remix, adapt and build upon this work, for
commercial use, provided the original work is properly cited.
See: http://creativecommons.org/licenses/by/4.0/
License URL
Sponsor
National Institute for Health Research
Grant Number
NIHR-CTF-2014-03-02
Subjects
Data Collection
Evidence Based Medicine
Health Economics
Information Technology
Pediatrics
1114 Paediatrics And Reproductive Medicine
Publication Status
Published