Trial Innovation Network

  • Key organizational components include the Trial Innovation Centers, Recruitment Innovation Centers, 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/TuftsUniversity

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, RockefellerUniversity, 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 activities at their Institutions, tailoring general Network plans into more specific action plans that are best suited for their Hubs.
  • The initial members at UC Davis include Dr. Ted Wun, Associate Dean for Research, and Dr. Kate Marusina, Director Clinical Trials Office

 

The Project must be a multi-center trial and a study with patient-oriented endpoints with potential for impact on clinical practice and operational innovation.

  1. The project is discussed with the CTSA Hub PI
  2. The Project is discussed with the NIH Program Officer at the institute where funding will be sought. The PO's support of the project is a necessary step for the submission
  3. Proposal is submitted to TIN via an on-line submission form
  4. You shodul receive a response from TIN 30 days after the submission
  5. The Project is approved for the initial consultation

 

1) Trial Services:

    • Set up Master Agreements with other sites
    • Set up a single IRB for the study
    • Recruitment planning consultation
    • Recruitment feasibility assessment
    • Standard recruitment materials
    • Engagement Studio

 

2) Trial Consultations. Goal of Comprehensive Consultation is to have proposal ready to submit for peer review

  • Protocol Design
  • Study and Budget Feasibility
  • Statistical Analysis Plan
  • Risk Assessment
  • Recruitment Plan/ Feasibility
  • Phenotype based Cohort Counts
  • Recruitment training

 

Consultations may lead to Trial Implementation:

  • Standard Agreement, CIRB
  • Recruitment Sites
  • Regulatory Support
  • Project management
  • Consent Forms, CRFs
  • Site Selection, Inititation, Training, Performance
  • Enrollment metrics
  • Recruitment Plan and tools
  • Data management
  • DSMB
  • Study Close out
  • Statistical Analysis
  • Publications