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

2. CTSA Program Spring Meeting
Uncovering grand opportunities in translational science

3. 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.

4. 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.

5. 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

6. 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.