Trial Innovation Network Uncovering Grand Opportunities Monica R. Shah, MD CTSA Program Meeting April 18, 2017

CTSA Program Spring Meeting Uncovering grand opportunities in translational science

Trial Innovation Network Long Term Goal Build national platform for clinical trials focused on operational innovation, operational excellence, and collaboration Year One Goal Build harmonized key elements of Trial Innovation Network GRAND Year 2 Goal Build National, Collaborative Site Based Research System Thank you very much. As you all know, the long-term goal of the Trial Innovation Network is to be a national platform for clinical trials that focuses on operational innovation, operational excellence, and very importantly – collaboration. Since July, the TIC and RIC teams have been hard at work building the key elements of the Network – a harmonized IRB system, contracting system, proposal process, and approaches to recruitment and retention. As we move into Year 2, our focus in going to be on leveraging the strength and experience of our CTSA Program Hubs to build a national, collaborative, and harmonized site based research system. Our grand opportunity to come together as a community of learning to address the critical site based roadblocks in clinical trials.

Site Based Research Roadblocks Workload, time, research a “secondary job” Complex institutional systems Regulatory and bureaucratic burdens Lack of harmonization of processes Variability in training and expertise of local study teams Roadblock We’re all acutely aware of the roadblocks in site based research – our investigators and research staff have huge workloads and research is often considered a secondary activity. Research teams have to navigate complex institutional systems and regulatory issues. There is a lack of harmonization of fundamental aspects of trials – from the organization of our protocols – to how we collect and submit data – and everything in between. There is also variability in the experience of our local study teams which often reduces efficiency and slows results.

Hub Liaison Teams Innovation through Collaboration NIH Industry Other Partners Medical Director Hub Liaison Team Research Staff Hub Liaison Team Manager CTSA Hub PI Hub Investigators Encourage Ideas Assist with TIN Proposals Identify Investigators for TIN Studies Innovation through Collaboration Dedicated Clinical Trial Catalyst Team Hub IRB Office Operationalize TIN CIRB TICs Trial Innovation Network Hub Liaison Team CTSA Program Hub Hub Contracts Office Operationalize Standard Agreements RIC We have a grand opportunity to bring together our Hub Liaison Teams as a national, collaborative force to address these critical roadblocks. Over the next year, we’re going to focus on bringing together our HLTs to work together to clear these roadblocks. The HLTS are charged with catalyzing research at a local level – to work with Hub investigators to encourage ideas and protocols, to work with local study teams to facilitate IRB review and contracting, operationalize Trial Innovation Network studies, and disseminate evidence-based approaches to recruitment and retention. We’re going to be asking the HLTs to embrace their role as a key partner in the Trial Innovation Network by providing feedback on Network processes, sharing ideas, and disseminating information. Ultimately, by working together we can create a national system that key partners can leverage to answer important scientific questions. Hub Recruitment Cohort Discovery Training Community Engagement Hub Research Teams Assist with Operationalizing TIN Studies

The Grand Opportunity A National Site Based Research System Over the next year, our goal is to innovate and harmonize site based research processes, increase site efficiency and quality, and accelerate timelines. Through the collaboration and strength of our Hub Liaison Teams, we hope to move one step closer to a vision of a national clinical trials highway – one that will allow us to efficiently test new therapies, develop treatments – and most importantly, improve the lives of our patients. That’s our grand opportunity.