scholarly journals Impact of clinical and patient pathway changes on paediatric research during the national COVID-19 response

2021 ◽  
pp. archdischild-2021-322865
Author(s):  
Pamela Dicks ◽  
Jürgen Schwarze ◽  
Paul Dimitri
2020 ◽  
Vol 27 (3) ◽  
pp. 213-231
Author(s):  
Annagrazia Altavilla ◽  
Viviana Giannuzzi ◽  
Mariangela Lupo ◽  
Donato Bonifazi ◽  
Adriana Ceci

Abstract The lack of paediatric medicines, including innovative and advanced ones, is a long-lasting and well-known problem at European and international levels. Despite the existing legal frameworks and incentives, children remain deprived of many kinds of therapy because of challenges faced in appropriately study and tailoring medicinal and other products for them. In this context, the necessity to foster paediatric research addressing unsolved and uncovered issues within a ‘translational approach’ has appeared. This article, after having clarified the concept of translational research in the perspective of the establishment of a European paediatric research infrastructure (RI), will identify and point out ethical, legal and regulatory issues particularly relevant in a children’s rights perspective. It concludes asking for the setting up of an adequate model of governance within a future RI, including adequate and independent ethical oversight and a pluridisciplinary common service dealing with ethical, legal and societal issues relevant for children.


2019 ◽  
Vol 48 (Supplement_1) ◽  
pp. i1-i15
Author(s):  
R Rogans-Watson ◽  
Y Graichen ◽  
J Dean ◽  
E Sobamowo ◽  
W Tan
Keyword(s):  

2021 ◽  
Vol 16 (4) ◽  
pp. S718
Author(s):  
K. Bogos ◽  
G. Gaffly ◽  
Z. Kiss ◽  
L. Tamási ◽  
G. Ostoros ◽  
...  

2018 ◽  
Vol 4 (4) ◽  
pp. 163-171
Author(s):  
Colin Hamilton ◽  
Robert Phaal ◽  
Mita Brahmbhatt ◽  
Peter Jarritt ◽  
Topun Austin

ObjectivesTo identify current ‘gaps’ in clinical practice or therapeutic knowledge of the care of neonatal neurointensive care patients and to determine the impact healthcare technologies can have on improving outcomes.DesignThe Cambridge Institute for Manufacturing’s (IfM) roadmapping methodology.SettingCambridge, UK.Participants16 delegates were selected through professional networks. They provided coverage of academia and clinical skills, as well as expertise in neonatology, engineering and technology development.Main outcome measuresA ‘strategic landscape’ has been developed with ‘landmarks’ identified as ‘trends or drivers’, ‘patient pathway experience and unmet needs’ and ‘enabling project or resources’. Priorities were voted on by delegates.Results26 strategic ‘landmarks’ were identified, and of these 8 were considered ‘trends or drivers’, 8 ‘patient pathway experience and unmet needs’ and 10 as ‘enabling project or resources’. Of these, five priorities for the future of neonatal neurocritical care were identified by a voting process: real-time video monitoring for parents; individualised management of preterm infants in neonatal neurocritical care based on real-time multimodal monitoring; continuous electroencephalogram monitoring for early seizure diagnosis; neuroprotection: understanding basic mechanisms; and sleep measurement.ConclusionsThrough the use of the IfM methodology, a list of priorities has been developed for future work into improving the experience and possible outcomes of newborn infants with brain injuries and their families. While not an exhaustive list, it provides the beginning for a national conversation on the topic.


2016 ◽  
Vol 23 (4) ◽  
pp. 325-349 ◽  
Author(s):  
Éloïse Gennet ◽  
Annagrazia Altavilla

Regulating paediatric research means searching for the balance between two valuable goals: protecting children while ensuring they benefit from safe and efficient medicines. Different legal instruments were adopted in the eu in order to regulate clinical trials, foster paediatric research and promote European and international ethical guidelines. However a new Regulation on clinical trials was adopted in 2014, and might change the current framework of paediatric research. How does the new Regulation 536/2014 foster research on children taking into account both the eu Paediatric Regulation and the eu Ethical Recommendations? Does it live up to the standards of the Directive 2001/20/ec and does it represent a step forward in accordance with international ethical guidelines? This article shows that, despite the adoption of new rules, many clarifications are still needed. Stakeholders involved in paediatric research have to play a driving role in the implementation process of the new Regulation.


Lung Cancer ◽  
2009 ◽  
Vol 63 ◽  
pp. S30-S31
Author(s):  
A. Zacharkiw ◽  
S. Rathinam ◽  
M.S. Kalkat ◽  
S. Roy-Choudhury

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