GHUCCTS

Trial Innovation Network

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  • Are you developing a multicentered proposal and need help identifying potential sites across the nation?
  • Are you planning an NIH submission or resubmission?
  • Do you need a coordinating center for your multi-site trial?
  • Do you need a central IRB for your multi-site trial?
  • Would you like to consider ways to leverage EHR data from up to 64 CTSA to inform study design?
The Georgetown-Howard Universities Center for Clinical and Translational Science (GHUCCTS) is excited to be part of the NIH Trial Innovation Network and we would like our institutional investigators to take advantage of this opportunity. There are two ways you can participate: (1) you may propose a multicentered clinical trial as a GHUCCTS investigator to leverage the nation-wide Trial Innovation Network; or, (2) you can be considered as a site participant for a multicentered clinical trial.

We would really like to hear from you if you are interested in being part of this clinical trial network opportunity. You can let us know your interest by contacting ghuccts@georgetown.edu.

Our TIN team is available to assist you. Review some of our select resources below, or visit the TIN Initial Consultation and Resources page for more information.

  • Single IRB Support

    Recent policy changes by the NIH and DHHS require the use of a single IRB of record for multisite research. The Network has established three single IRBs (SIRBs) to help meet this requirement. We will provide support, resources, tools, and a web-based platform (IREx) to ensure all site investigators understand how to use a SIRB at their institution, from initial submission to study closeout. The SIRBs use the SMART IRB Authorization Agreement as the basis for reliance.

    Learn more about costs for single IRB review and coordination here.

  • EHR-Based Cohort Assessment

    This resource helps investigators consider ways to use Electronic Health Record (EHR) data to inform study design and potential site selection. Expect expert clinical and technical review of a study’s goal recruitment population and high-level assessment of computable phenotyping. Funded projects may also request support to organize the distribution of phenotype algorithms to potential CTSA sites and collate results.

  • Study Design

    Discussions may involve the study goals and aims, the methodology, statistical and regulatory considerations, subject recruitment, schedule of assessments, or study interventions. The goal is to identify potential barriers to successful study completion and propose solutions.

  • Efficacy-to-Effectiveness (E2E) Trial Design

    An E2E or EE2 consultation will review the evidence required by various stakeholders, such as regulators, payers, patients, healthcare providers, and physicians. This information will be incorporated into the design of a prospective study.

    The consultation may include:

    • working with the investigator to design a study that includes both efficacy and effectiveness endpoints,
    • providing advice on suitable populations to include in the effectiveness phase of the trial,
    • creating a statistical analysis plan, and
    • identifying the role of the Data Safety Monitoring Board in moving from the efficacy to the effectiveness phase.
As of December 20, 2019:

  • 220 proposal have been submitted to the TIN to receive network support ranging across 59 therapeutic areas (Cardiovascular diseases 17%, neurology 8%, oncology 5%, pulmonary diseases 5%, behavior medicine (clinical) 3%).
  • 15 NIH Institutes and Centers have been engaged.
  • Strengthen your multi-centered proposal

    The NIH National Center for Advancing Translational Science (NCATS) established the Trial Innovation Network (TIN) to provide resources to assist with implementing multi-center clinical trials. You may have an opportunity to leverage several of the TIN resources including site identification; cohort discovery; and efficient implementation for your multicenter trial through the existing TIN infrastructure (e.g., standardized agreements, NIH NCATS funded single IRBs) by submitting a TIN proposal.

    What is a TIN proposal?

    • Do you have a multi-centered grant application that didn’t get funded and you plan on re-submitting?
    • Do you have a multi-centered funded trial and you’d like to potentially use TIN services (e.g. identify additional sites, develop recruitment materials that can be used nationally)?

    If yes, you may want to consider submitting a proposal to the TIN.

    Proposals submitted to the TIN receive an initial consultation during which the assigned TIC/RIC and the study investigator meet to consider the proposed study. Topics covered during these meetings may include the underlying scientific premise, the study outcomes, approaches to statistical analyses, and other discrete services. Investigators should identify the top two or three areas of the initial consultation they would like to prioritize. In addition, the Network partner will focus on operational innovation for the study and will leverage the expertise and resources of the CTSA program hubs.

  • Increase your federally-funded research portfolio

    Investigators across the nation are utilizing the Trial Innovation Network to identify collaborators for their multicentered trial. Since 2018, GHUCCTS has received more than 30 opportunities to collaborate with investigators across the nation. We would love to share the opportunity with you as a potential site investigator.

    Please complete this form so we can share opportunities that match your research interest.

TIN Interest Form:
PI Name
PI Email
Research Area of Interest
Primary Institution
I am interested in
Availability
How did you hear about this opportunity?
 

TIN Collaboration Webinars

The Trial Innovation Network (TIN) Collaboration Webinars feature CTSA Program members who share expertise, methods and/or best practices to improve the way trials are conducted.

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