The Trial Innovation Network is a new collaborative initiative of CTSA Program and is composed of three key organizational partners – the Recruitment Innovation Center (RIC), the Trial Innovation Centers (TICs), and the CTSA Program Hubs.
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 (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:
- Trial Innovation Network Central IRB System (uses the SMART IRB Authorization Agreement) – Flexible and efficient IRB review for multicenter studies. Johns Hopkins University, Vanderbilt University Medical Center, and University of Utah serve as the reviewing IRBs for the Trial Innovation Network.
- Standard Agreements System
- Streamlined protocols – TIC and RIC collaboration to develop optimized, streamlined protocols. Will use NIH-FDA Protocol Template.
- Harmonized IT tools and approaches (e.g., tools for recruitment using the electronic health record)
- Systematic approaches to engagement, recruitment, and retention. Data-driven recruitment strategies.
The CTSA Program Hubs are the frontline of the Trial Innovation Network. The multi‐disciplinary Trial Innovation Network Hub Liaison Teams will lead scientific, training, and implementation aspects of the Trial Innovation Network. They will use their experience and knowledge of the local environment to innovatively operationalize the Network at their Institutions, tailoring general Network plans into more specific action plans best suited for their Hubs.
The Hub Liaison Team serves as the gateway for WCM investigators considering using the Clinical Data Research Networks (CDRNs), such as PCORNet, and the Trial Innovation Network (TIN), which has linked all 64 CTSA institutions into a single clinical research network ready to engage in multicenter studies using highly efficient processes such as a central IRB and master clinical trial agreements. Services provided by the HLT include:
- Access to requests for EHR data and/or collaborators through the Clinical Data Research Networks
- Access to resources to assist from planning through study design, including identifying funding opportunities, grant development, informatics, biostatistics, and other services
- Assistance with completion of the TIN Proposal Submission Form
Contact: TIN Manager Pankaj Patel at pap9083@med.cornell.edu