Download Talking points - Trial Innovation Network

Trial Innovation Network: Early Vision and Goals
The Trial Innovation Network is a new collaborative initiative of CTSA Program and is composed of three key
organizational partners – the CTSA Program Hubs, the Trial Innovation Centers (TICs), and the Recruitment Innovation
Center (RIC).
Trial Innovation Network – Vision and Mission
The vision for the Trial Innovation Network is to innovatively address critical roadblocks in clinical trials and accelerate
the translation of novel interventions into life-saving therapies. The Trial Innovation Network is a collaborative national
network that focuses on operational innovation, operational excellence, and collaboration and will leverage the
expertise and resources of the CTSA Program. The Trial Innovation Network will feature a single IRB system, master
contracting agreements, quality by design approaches, and a focus on evidence-based strategies to recruitment and
patient engagement. The goal of the Trial Innovation Network is to not only execute trials better, faster, and more costefficiently but, importantly, to be a national laboratory to study, understand and innovate the process of conducting
clinical trials.
The investigators are currently building the key elements of the Trial Innovation Network. The goal is to start early
projects as soon as possible and collaborate with other NIH Institutes and partners to launch clinical trials in 2017.
What Are the Key Components of the Trial Innovation Network?
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Trial Innovation Network
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Key organizational components include the TICs, RIC, and CTSA Program Hubs
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All are key partners of the Trial Innovation Network and make unique and essential contributions
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Other important partners include NIH Institutes, other federal and non-federal stakeholders,
researchers, patients, providers, and the public
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Trial Innovation Centers (TICs)
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Innovation Centers focused on operational excellence, operational innovation, and quality by design
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The TICs are charged with coordinating and providing innovative, high quality operational support for
clinical trials.
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TICs – Duke University/Vanderbilt University; University of Utah; Johns Hopkins University/Tufts
University
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Recruitment Innovation Center (RIC)
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Innovation Center focused on innovative and evidence-based approaches to participant recruitment,
retention, and engagement
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The RIC will provide tools and services to enhance participant recruitment and retention
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RIC – Vanderbilt University with partners at Columbia University, the Ohio State University, Rockefeller
University, and the University of Utah
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Trial Innovation Network Hub Liaison Teams
Trial Innovation Network Talking Points – 11/28/2016
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Frontline of the Trial Innovation Network. The Trial Innovation Network Hub Liaison Teams (formerly
referred to as TIC Liaisons and RIC Liaisons) will lead the Network at the local level and will connect the
Hubs to the TICs and RIC.
Trial Innovation Network Hub Liaison Teams will use their experience and knowledge of the local
environment to coordinate Trial Innovation activities at their Institutions, tailoring general Network
plans into more specific action plans that are best suited for their Hubs.
Key Elements of the Trial Innovation Network
Key elements of the Trial Innovation Network that are currently being developed include:
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Single IRB reliance model system – Flexible and efficient IRB review for multicenter studies
Master contracting system
Streamlined protocols – Master protocol and clinical research form (CRF) templates
Harmonized IT tools and approaches (e.g., tools for recruitment using the electronic health record)
Data-driven recruitment strategies
Trial Innovation Network Proposal Intake Process
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The Trial Innovation Network is now accepting Network Project Proposals. Visit the Trial Innovation Network
Website to submit a Network Project Proposal.
Level 1 Network Projects (Basic Consultation or Service)
o Trial Innovation Network provides specific consultations or services (up to a pre-specified threshold) but
the Trial Innovation Network is not responsible for recruiting patients or managing study data.
Level 2 Network Projects (Comprehensive Consultation)
o The Trial Innovation Network provides comprehensive in-kind consultations (up to a pre-specified
threshold) to develop a proposal into a protocol. A Comprehensive Consultation could include an array
of enhanced consultations such as in-depth protocol development, statistics, recruitment feasibility,
recruitment plans, study budgets, and other key elements. During the Comprehensive Consultation,
input from the CTSA Program Hubs on the protocol and proposed study budgets would be sought.
o After a Level 2 Network Project Comprehensive Consultation, the Principal Investigator has the option to
independently develop an application for a clinical trial using the TICs/RIC as the Coordinating Centers
and the Hubs as the recruitment sites.
How the Trial Innovation Network Project Proposal Process Will Work
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Investigators will submit Trial Innovation Network Project Proposals (Level 1 and Level 2 Network Project
Proposals) through the Trial Innovation Network website portal
The proposals will be reviewed by the proposal assessment team for feasibility, potential for operational
innovation, resource requirement, and ability of the Trial Innovation Network to deliver services/consults.
Approved proposals will be assigned to a TIC or a RIC.
Services/consultations will be provided immediately after decisions are made
What is the Added Value of the Trial Innovation Network?
The current state of clinical trials – across the board and in all disciplines – presents many opportunities for
improvement. The Trial Innovation Network is designed to be a complementary resource and an option for investigators
and NIH Institutes to optimize the clinical trials enterprise.
Trial Innovation Network Talking Points – 11/28/2016
Added Value for Investigators:
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One-stop shopping to implement clinical studies so investigators can focus on the scientific question
TICs and RICs – expertise in operational innovation and operational excellence
CTSA Program hubs – broad expertise; large, diverse patient populations
More competitive clinical trials applications submitted to NIH ICs
Added Value for NIH Institutes and Other Partners:
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Shared goal to complete trials and studies on time and within budget
Shared NIH mission to innovate and transform clinical trials and optimize stewardship
NCATS welcomes your input, engagement, and partnership as we develop the Trial Innovation Network.
Program Contacts: [email protected], [email protected], [email protected], [email protected],
[email protected]
Trial Innovation Network Talking Points – 11/28/2016