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Improving clinical paediatric research and learning from COVID-19: recommendations by the Conect4Children
Athimalaipet V Ramanan1,2, Neena Modi3,4, Saskia N de Wildt5,6
1University Hospitals Bristol NHS Foundation Trust, Bristol, UK. avramanan@hotmail.com.
Insights
The COVID-19 pandemic accelerated pediatric clinical research innovations. The Conect4children network recommends retaining these advancements to improve efficiency and equity in pediatric medicine development.
Area of Science:
- Paediatric medicine development
- Clinical research methodology
- Public health and healthcare systems
Background:
- The COVID-19 pandemic significantly impacted healthcare, driving innovation in clinical research, particularly for pediatric populations.
- The Conect4children (c4c) network, a European collaboration of academic and industry partners, focuses on facilitating new medicine development for children.
- c4c comprises 35 academic and 10 industry partners across 20 European countries, involving over 50 third parties and approximately 500 affiliated partners.
Purpose of the Study:
- To summarize key aspects of pediatric clinical research stimulated by COVID-19.
- To recommend practices for regulators, sponsors, and investigators to enhance future pediatric studies.
- To improve the efficiency, reduce costs and burden, and ensure research equity in pediatric medicine and non-interventional studies.
Main Methods:
- Review and synthesis of pediatric clinical research practices influenced by the COVID-19 pandemic.
- Incorporation of industry perspectives, regulatory considerations, and infrastructure requirements.
- Inclusion of parent-patient-public involvement in the evaluation of research innovations.
Main Results:
- Identification of research innovations in pediatrics spurred by the pandemic.
- Development of recommendations for enhancing the efficiency and equity of pediatric clinical trials.
- Assessment of progress in international harmonization of pediatric research.
Conclusions:
- Lessons learned from COVID-19 pediatric studies offer opportunities to improve future research.
- Retaining pandemic-driven innovations can lead to more efficient, cost-effective, and equitable pediatric medicine development.
- Continued international collaboration and harmonization are crucial for advancing pediatric research globally.
Background:
The COVID-19 pandemic has had a devastating impact on multiple aspects of healthcare, but has also triggered new ways of working, stimulated novel approaches in clinical research and reinforced the value of previous innovations. Conect4children (c4c, www.conect4children.org ) is a large collaborative European network to facilitate the development of new medicines for paediatric populations, and is made up of 35 academic and 10 industry partners from 20 European countries, more than 50 third parties, and around 500 affiliated partners.
Methods:
We summarise aspects of clinical research in paediatrics stimulated and reinforced by COVID-19 that the Conect4children group recommends regulators, sponsors, and investigators retain for the future, to enhance the efficiency, reduce the cost and burden of medicines and non-interventional studies, and deliver research-equity.
Findings:
We summarise aspects of clinical research in paediatrics stimulated and reinforced by COVID-19 that the Conect4children group recommends regulators, sponsors, and investigators retain for the future, to enhance the efficiency, reduce the cost and burden of medicines and non-interventional studies, and deliver research-equityWe provide examples of research innovation, and follow this with recommendations to improve the efficiency of future trials, drawing on industry perspectives, regulatory considerations, infrastructure requirements and parent-patient-public involvement. We end with a comment on progress made towards greater international harmonisation of paediatric research and how lessons learned from COVID-19 studies might assist in further improvements in this important area.
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