Trial Innovation Unit’s (TIU) aim is to increase the center’s ability to implement multisite studies quickly and efficiently, in collaboration with the national Trial Innovation Centers (TICs). The TIU is comprised of a dedicated liaison and interdisciplinary committee to help streamline the study start-up process and develop pathways that optimize coordinated budgeting, contracting and regulatory approvals, utilizing central IRBs and master clinical trial agreements. The TIU will also implement targeted micro-interventions to improve efficiency and assess their impact through the use of low-cost and low-burden experimental techniques. This data-driven approach will help establish sustainable national resources that can be disseminated through the TICs to all CTSA hubs.
Multisite clinical trials are often hampered by organizational boundaries, information silos, disparate systems, and non-standardized processes. The TIU will therefore centralize multi-site trial management across all of our partner institutions, providing a robust, standardized and accessible infrastructure to facilitate rapid clinical trial implementation in coordination with the national TICS. The TIU will actively engage with the TICs to stay informed regarding national SOPs, templates, tracking software and other innovative methods to ensure that they are implemented throughout the CTSC hub.
If delays or barriers are identified, the TIU will develop targeted micro-interventions to “turn the curve” to get lagging studies back on track. The TIU will also assess the efficacy of interventions and, if deemed suitable, disseminate it to multiple centers for testing prior to eventually rolling it out to other CTSA hubs. This feedback loop will allow the TIU to benefit from the national consortium, as well as provide the TICs with best practices that have proven successful at local sites.