Harmonizing quality improvement metrics across global trial networks to advance paediatric clinical trials delivery

Abstract

Abstract 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, that focus on novel drugs and work with industry and academic Sponsors, Institute for Advanced Clinical Trials for Children, the Maternal Infant Child and Youth Research Network and conect4children have developed metrics. We identified the goal and methodology of each network to select metrics. We described the metrics of each network through a survey. We mapped consistency and divergence and came to consensus about core metrics that these 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 (5 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. 15 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. Collaborative work to define inter-operable metrics globally is necessary and an approach to this is outlined.