Early Vision for the CTSA Program Trial Innovation Network: A Perspective from the National Center for Advancing Translational Sciences

The Trial Innovation Network aims to achieve this mission by embedding innovation and critical evaluation into the clinical trials process, building quality into the design of protocols, aligning Network infrastructure with existing local institutional infrastructure, streamlining IRB and contracting processes, employing novel approaches to project management, and using data‐driven approaches to optimize clinical trials at every point—from protocol design to the publication of results. Trial Innovation Network—Roles and responsibilities of key partners Key partners of the Trial Innovation Network Trial innovation centers Will coordinate and provide innovative high‐quality operational support for clinical trials and studies Will serve as central IRBs for Trial Innovation Network trials and studies Recruitment innovation center Will provide tools and services to enhance participant engagement, recruitment, and retention CTSA Program hubs Frontline of the Trial Innovation Network Network hub liaison teams will lead the Trial Innovation Network at the local level and will connect hubs to TICs and RIC CTSA, Clinical and Translational Science Award; IRB, institutional review board; RIC, Recruitment Innovation Center; TIC, Trial Innovation Center. The Recruitment Innovation Center will provide tools and services to enhance participant engagement, recruitment, and retention and will focus on minority and underrepresented participant engagement and recruitment, optimizing the informed consent process, training Hub Liaison Teams on best practices to optimize recruitment, and leveraging the electronic health record, other existing databases, and novel technology to boost recruitment and retention. Leveraging innovations from the CTSA Program Key elements of the Trial Innovation Network will build on the established local and regional strengths at the CTSA Program hubs and groundbreaking work by CTSA Program investigators on the standard agreement template, standard IRB reliance tools, standards for good clinical practice training and scientific review, and tools to facilitate data‐driven recruitment and retention.