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Harmonizing Quality Improvement Metrics Across Global Trial Networks to Advance Paediatric Clinical Trials Delivery
Sabah Attar1,2, Angie Price3, Collin Hovinga4
1Department of Women's and Children's Health, Liverpool Women's NHS Foundation Trust, University of Liverpool, Crown Street, Liverpool, L8 7SS, UK. sgattar@liverpool.ac.uk.
Insights
Global collaboration is needed to speed up paediatric drug approvals. This study compared metrics across three paediatric networks, finding disparities that highlight opportunities for unified, interoperable approaches to improve clinical trial conduct.
Area of Science:
- Clinical pharmacology
- Paediatric research
- Health services research
Background:
- Paediatric drug approvals face significant global delays despite ongoing efforts.
- Inter-network collaboration is crucial to overcome these challenges.
- This study initiates efforts to enhance interoperability among paediatric networks by comparing clinical trial conduct metrics.
Purpose of the Study:
- To compare the drivers and content of clinical trial conduct metrics used by three distinct paediatric networks.
- To identify commonalities and disparities in metric development methodologies.
- To lay the groundwork for developing shared, interoperable metrics across networks.
Main Methods:
- Examined the metric identification methodologies of three paediatric networks: Institute for Advanced Clinical Trials for Children, Maternal Infant Child and Youth Research Network, and conect4children.
- Described the specific metrics developed by each network.
- Mapped metric consistency to identify core, shareable metrics.
Main Results:
- Metric selection drivers varied: site quality improvement (11 metrics), network performance (13 metrics), or both (5 metrics).
- Key metric domains included research capacity, site feasibility, trial start-up, and recruitment.
- Fifteen core metrics for trial start-up and conduct were identified, with site approvals being a common theme across all networks.
Conclusions:
- Significant disparities exist in the drivers, methodologies, and specific metrics used by paediatric networks.
- Addressing these disparities is essential for a unified approach to accelerate paediatric drug approvals.
- The findings support collaborative global efforts to define interoperable metrics for paediatric clinical trials.
Background:
Despite global efforts to improve paediatric clinical trials, significant delays continue in paediatric drug approvals. Collaboration between research networks is needed to address these delays. This paper is a first step to promote interoperability between paediatric networks from different jurisdictions by comparing drivers for, and content of, metrics about clinical trial conduct.
Methods:
Three paediatric networks, Institute for Advanced Clinical Trials for Children, the Maternal Infant Child and Youth Research Network and conect4children, have each developed metrics to address delays and create efficiencies. We identified the methodology by which each network identified metrics, described the metrics of each network, and mapped consistency to come to consensus about core metrics that networks could share.
Results:
Metric selection was driven by site quality improvement in one network (11 metrics), by network performance in one network (13 metrics), and by both in one network (five metrics). The domains of metrics were research capacity/capability, site identification/feasibility, trial start-up, and recruitment/enrolment. The network driven by site quality improvement did not have indicators for capacity/capability or identification/feasibility. Fifteen metrics for trial start up and conduct were identified. Metrics related to site approvals were found in all three networks. The themes for metrics can inform the development of 'shared' metrics.
Conclusion:
We found disparity in drivers, methodology and metrics. Tackling this disparity will result in a unified approach to addressing delays in paediatric drug approvals. Collaborative work to define inter-operable metrics globally is outlined.
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