Trial Innovation Network

The Trial Innovation Network (TIN) is a new collaborative initiative of the Clinical and Translational Science Awards (CTSA) Program to address critical roadblocks in clinical trials and accelerate the translation of novel interventions into life-saving therapies. The network focuses on operational innovation, operational excellence, and collaboration while leveraging the expertise and resources of the CTSA Program. Features include a single institutional review board system, master contracting agreements, quality by design approaches, and a focus on evidence-based strategies to recruitment and patient engagement. Launched to facilitate multi-site clinical studies, the Network is composed of three key organizational partners – the CTSA Program Hubs, the Trial Innovation Centers (TICs), and the Recruitment Innovation Center (RIC). UC San Diego Altman Clinical and Translational Research Institute is a TIN Hub Liaison Team.

What Are the Key Components of the Trial Innovation Network?

Trial Innovation Network

• Key organizational components include the TICs, RIC, and CTSA Program Hubs
• All are key partners of the Trial Innovation Network and make unique and essential contributions
• Other important partners include NIH Institutes, other federal and non-federal stakeholders, researchers, patients, providers, and the public

Trial Innovation Centers (TICs)

• Innovation Centers focused on operational excellence, operational innovation, and quality by design
• The TICs are charged with coordinating and providing innovative, high quality operational support for clinical trials
• TICs – Duke University/Vanderbilt University; University of Utah; Johns Hopkins University/Tufts University

Recruitment Innovation Center (RIC)

• Innovation Center focused on innovative and evidence-based approaches to participant recruitment, retention, and engagement
• The RIC will provide tools and services to enhance participant recruitment and retention
• RIC – Vanderbilt University with partners at Columbia University, the Ohio State University, Rockefeller University, and the University of Utah

Trial Innovation Network Hub Liaison Teams

• Frontline of the Trial Innovation Network. The Trial Innovation Network Hub Liaison Teams 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.
• UC San Diego Altman Clinical and Translational Research Institute (ACTRI) is a TIN Hub Liaison Team

Key Elements of the Trial Innovation Network

Elements currently being developed include:

• Single IRB reliance model system – Flexible and efficient IRB review for multicenter studies
  • SMART IRB Exchange – The Trial Innovation Network is utilizing the Streamlined, Multisite, Accelerated Resources for Trials (SMART) IRB Exchange to support single IRB review of all Network studies. The SMART IRB Exchange is an IT platform, supported by the Duke/Vanderbilt TIC, used to initiate or activate IRB reliance for a given study, as well as to document ongoing IRB approvals for the study, promote transparency, and facilitate communication.
• 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

• 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)
  • 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)
  • 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.
  • 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.

Please note: Prior to submitting a proposal to the NIH, UC San Diego investigators are required to contact the ACTRI Hub Liaison Team to discuss their proposal and submit it for a pre-review by the ACTRI Scientific Review Committee. Please contact ACTRI team medical director Mark S. Wallace or team project manager Archana Bhatt to begin the consultation and pre-review process.

ACTRI TIN HUB Liaison Team