The Johns Hopkins University (JHU) Trial Innovation Center (TIC) is a well-established, highly functioning team with a goal of dramatically improving the conduct, efficiency and impact of multisite randomized controlled trials. The TIC includes experienced trial scientists, project managers, statisticians, and trial staff with external collaborators from 5 research intensive CTSA Hubs. BIOS, a JHU trials research group, will operationally convene this group and provide staff to execute version 2.0 of the Trial Innovation Network (TIN) program and its specific tasks as previously and collaboratively determined by the TICs, RICs and NCATS. During TIN 1.0 our joint expertise Developed and Demonstrated new methods for multicenter trials and provided these methods via the TIN platform to individual CTSA Hub PIs wishing to perform multisite randomized trials. This proposal is derived from our established track record of trial execution accomplishments and trial science innovations, which will facilitate dissemination of these methods and specific trial tools towards the NCATS goal to speed translational research. We identified needs not met in TIN 1.0 including: trial training of hub staff, training in operations rather than strategy, preceptorship for Hub CCC/DCC capabilities, and need for up-to-date operational methods/tools. In TIN 2.0 we will further Develop new trial tools and methods for testing their ease of implementation at CTSA hubs, Demonstrate the effectiveness of this approach, and Disseminate broadly to CTSA Hubs, by using case studies and didactics. We propose an integrated, coordinated, multi-stakeholder TIC process to improve the efficiency and quality of multi-site trial initiation and subsequent execution by CTSA sites. Our group of external collaborators will work as a sample of the larger CTSA-TIN consortium to develop Hub implementation and dissemination approaches on both a case- and consortium-wide basis. The JHU TIC will leverage operational activities in CTSA trials implementation to study novel operational innovations that improve participant engagement, intervention adherence and measurement of trial endpoints. We will measure benefits using explicit efficiency- and quality-focused metrics to test these innovations. The scientific purpose of our team’s efforts will be to demonstrate that TIC innovations in trial design, execution, and evaluation can lead to better trial performance, including faster start-up, faster completion, greater protocol compliance and more precise endpoints. We will disseminate results of validated CTSA-TIN innovations produced from consortia trials to CTSA Hub clinical trial teams and research trainees. We will collaborate with NCATS to utilize the platform demonstrated in TIN 1.0 to engage and equip a multisite randomized clinical trial workforce through the CTSA Hubs to perform trials faster and at a higher quality in TIN 2.0.

The Johns Hopkins University (JHU) Trial Innovation Center (TIC) represents an established, high functioning team of multisite trial PIs, experienced trial scientists, project managers, statisticians, and trial staff, including external trialist collaborators from 5 CTSA Hubs, that will leverage operational services and trial science in CTSA trials to develop and study novel operational innovations that improve participant engagement, protocol compliance and measurement of trial endpoints. The team will demonstrate that TIC innovations in trial design, execution, and evaluation can lead to better trial performance, including faster start-up, faster completion, greater intervention adherence and more precise endpoints leading to enhanced efficiency and impact. The JHU TIC will build capacity by disseminating results of valid CTSA-TIN innovations tested within consortium trials to CTSA clinical trial teams and research trainees.