Summary
This report describes the Trial Innovation Network, a partnership between the Clinical and Translational Science Award (CTSA) Consortium and the National Institutes of Health, established to address operational and recruitment challenges in multicenter randomised clinical trials. The network has created integrated support systems spanning trial design, data management, and recruitment across more than 60 academic institutions, with particular emphasis on enhancing diversity in research participation and streamlining trial conduct. The authors present this infrastructure and its innovations as a potentially transferable model for other clinical trial networks seeking to accelerate the translation of novel interventions to clinical practice.
UK applicability
The CTSA network model may inform UK clinical trial infrastructure development, particularly regarding integration of multiple research institutions and standardisation of trial support services. However, direct applicability would require adaptation to the UK's distinct National Health Service structure, regulatory environment, and existing clinical research networks such as NIHR.
Key measures
Number of integrated CTSA institutions, trial support services deployed, recruitment innovation initiatives, trial start-up timelines, participant engagement metrics, and network response to public health emergencies
Outcomes reported
The study documented the Trial Innovation Network's integration of over 60 CTSA institution programme hubs and described the development of novel tools, operational services, recruitment models, and processes designed to reduce trial start-up delays, enhance recruitment diversity, and improve trial quality and efficiency.
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