c4c experts have published ‘Improving clinical paediatric research and learning from COVID-19: recommendations by the conect4children expert advice group’ in Pediatric Research.
The COVID-19 pandemic has resulted in some challenges which c4c partners have had to contend with in their clinical trial operations. COVID-19 affected access to patients; laboratories; study materials; and availability of clinical research staff. Despite this, COVID-19 led many groups to implement novel ways of working to ensure paediatric trials continue at high standards.
This peer review publication provides an overview of paediatric clinical research stimulated and reinforced by COVID-19, and provides recommendations to regulators, sponsors, and investigators on how they can retain this for the future. Lessons learned include:
- improving trial efficiency around aspects on planning paediatric studies, safety and innovative pharmacometrics
- industry perspectives through valuing clear and timely communication between stakeholders to ensure the safety of children and clinical data integrity
- regulatory considerations, such as adopting new regulatory processes for COVID-19 research as well as other ongoing studies
- infrastructure requirements by accelerating applications and measures which reduce person-to-person contact and support remote data gathering and study monitoring.
Although COVID-19 altered normal study design systems, it’s not clear if the involvement of children, young people, and families maintained momentum. Therefore, this publication recommends promoting existing networks of children, young people, and parents. In c4c, we are piloting a strategic feasibility advice service providing access to professional experts and networks of patients and parents, to provide advice on paediatric study design and conduct.
To read the publication in full click here