The vision of the ACT project is to create a CTSA federated network to increase accrual to clinical trials.
We chose i2b2 and SHRINE because its functionality meets our objectives to increase accrual to the nation’s highest priority clinical trials. In contrast to PCORNet, i2b2and SHRINE were designed to accommodate diverse data, including genomic, patient-reported, and specimen data. Importantly, SHRINE can be layered on top of non-i2b2 platforms to enable the development of a common query tool that can be used across a broad range of CTSA sites. It has been developed in lockstep with development of a robust regulatory framework. It is not just a query tool-- it is a complete system that includes full workflows for joining de-identified data with demographics. i2b2 supports SMART (www.smartplatforms.org), which will enable rapidly forming ecosystem of modular apps for reviewing cases, randomizing patients, patient outreach, and patient consent). Most importantly, i2b2/SHRINE has a large installed base and vibrant open source user communities demonstrating functionality and proof of concept. We are committed to adapting both i2b2and SHRINE over the next several years to the needs of the CTSA Federated Network. Neither the informatics architecture nor the nomenclature is final and we (all of our sites) are eager to improve these tools to best serve the entire Federated Network.