Johns Hopkins-Tufts Trial Innovation Center

点击翻译按钮获取中文摘要

The JHU-Tufts Trial Innovation Center (TIC) represents an established, functioning team of multisite trial PIs, experienced lead managers, administrators, and scientists at both Johns Hopkins University (JHU) and Tufts University (including its longstanding partners, the Harvard Clinical Research Institute (HCRI) and Massachusetts Institute of Technology (MIT)). BIOS, a JHU trials research group, will operationally convene this group and provide staff to execute the required TIC program and its specific tasks. Our joint expertise developing new methods for multicenter trials will be provided to the TIC program whereby individual TIC trials will be executed with excellence and innovations incorporated into subsequent trials. This proposal is derived from our established track record of trial execution accomplishments and innovations, which will facilitate progress towards the NCATS goal of producing three robust TICs to speed translational research. We will Develop, Demonstrate, and Disseminate an integrated, coordinated, multi-stakeholder TIC process to improve the efficiency and quality of multi-site trial initiation and subsequent execution by sites. The JHU-Tufts TIC will leverage operational service in CTSA trials implementation to study novel operational innovations. The scientific purpose of our team's efforts will be to demonstrate that TIC innovations in trial design, execution, and evaluation will lead to better trial performance, including faster start-up, faster completion, and greater protocol compliance. We will measure benefits using explicit efficiency and quality-focused metrics to test these innovations. We will disseminate results of valid CTSA-TIC innovations produced from consortia trials to current clinical trial teams and research trainees. We hope to collaborate with NCATS to produce a platform that allows investigators to perform trials faster and at a higher quality.