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Priority Needs for Conducting Pandemic-relevant Clinical Research With Children in Europe: A Consensus Study With
Micaela Gal1, Nina Gobat1, Nicholas A Francis1
1From the School of Medicine.
Insights
Pediatric clinician-researchers identified key priorities for conducting infectious disease pandemic research in Europe. Streamlining regulatory processes and improving collaboration are crucial for advancing children
Area of Science:
- Pediatric Infectious Diseases
- Clinical Research
- Pandemic Preparedness
Background:
- Infectious disease (ID) pandemics present a significant global health challenge, disproportionately impacting vulnerable populations like children.
- Pediatric clinical research is vital for enhancing child healthcare during pandemics and mitigating risks from interventions lacking pediatric evidence.
- Unique aspects of ID pandemics necessitate specialized processes for effective clinical research.
Purpose of the Study:
- To achieve consensus among European pediatric clinician-researchers regarding priorities for feasible clinical research during infectious disease pandemics.
- To identify essential structural and operational requirements for conducting pediatric pandemic research.
Main Methods:
- A two-stage mixed-methods study involving European pediatric clinician-researchers experienced in pediatric ID research.
- Stage 1: Expert stakeholder workshop and interviews to explore experiences and identify facilitators for pandemic research.
- Stage 2: Online consensus survey to determine pediatric clinician-researchers' priorities for enabling ID pandemic research.
Main Results:
- Twenty-three researchers participated in the workshop, and 39 completed the survey.
- Key priorities centered on regulatory and structural needs: clarifying the European Clinical Trials Directive for pediatric pandemic research.
- Simplified regulatory pathways for clinical sample and data research, alongside enhanced researcher-regulatory body relationships, were identified as critical.
Conclusions:
- The current regulatory environment requires modification to better facilitate and enhance pediatric research during pandemic scenarios.
- Findings offer evidence for policymakers and regulators to develop strategies for improving pediatric pandemic research infrastructure.
- Addressing identified priorities can strengthen the evidence base for pediatric interventions during global health crises.
Background:
Infectious disease (ID) pandemics pose a considerable global threat and can disproportionately affect vulnerable populations including children. Pediatric clinical research in pandemics is essential to improve children's healthcare and minimize risks of harm by interventions that lack an adequate evidence base for this population. The unique features of ID pandemics require consideration of special processes to facilitate clinical research. We aimed to obtain consensus on pediatric clinician-researchers' perceptions of the priorities to feasibly conduct clinical pediatric pandemic research in Europe.
Methods:
Mixed method study in 2 stages, recruiting pediatric clinician-researchers with experience of conducting pediatric ID research in clinical settings in Europe. Stage 1 was an expert stakeholder workshop and interviews. Discussions focused on participant's experience of conducting pediatric ID research and processes to facilitate pandemic research. Information informed stage 2, an online consensus survey to identify pediatric inician-researchers priorities to enable ID pandemic research.
Results:
Twenty-three pediatric clinician-researchers attended the workshop and 39 completed the survey. Priorities were primarily focused on structural and operational requirements of research design and regulation: (1) clarity within the European Clinical Trials Directive for pediatric pandemic research; (2) simplified regulatory processes for research involving clinical samples and data; and (3) improved relationships between regulatory bodies and researchers.
Conclusions:
Results suggest that changes need to be made to the current regulatory environment to facilitate and improve pediatric research in the pandemic context. These findings can provide expert evidence to research policy decision-makers and regulators and to develop a strategy to lobby for change.
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