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.

  • HEAL Initiative: RFA-NS-20-028
    The NIH will re-release RFA-NS-20-028 (UG3/UH3) on January 20, 2020 with an expected submission deadline on March 24, 2020 and GHUCCTS Trial Innovation Network Hub Liaison Team is here to help facilitate the process.

    Through this re-release, HEAL Initiative: Pain Management Multisite Effectiveness Research Network (ERN): Clinical Trial Planning and Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required), NIH is soliciting up to two additional ERN trials that will address the high priorities below. NIH will prioritize the following areas of interest to generate evidence-based pain management best practices for the use of existing medications or devices for specific pain conditions. The guidelines should be of use to providers in primary care, emergency departments, dental clinics, and hospital settings. The pain conditions of high priority are:

    • pain management in emergency departments, dental clinics, primary care, and hospitals;
    • chronic overlapping pain conditions;
    • best practices for effective analgesics when appropriate;
    • pain management in individuals at risk of or with OUD;
    • pain management in those with co-occurring mental health disorders; and
    • Non-cancer pain management in persons with medical comorbidities

    Research testing behavioral interventions to manage pain will not be considered as high priority projects since several currently funded HEAL trials are testing behavioral interventions for pain management. Investigators wishing to test the effectiveness of behavioral interventions should contact program officials from individual ICs to find an appropriate FOA. Research testing software or decision-making tools that help providers and patients determine the most effective and safe methods for pharmacological or device pain management are allowed.

    This multisite effectiveness research consortium will be part of the NIH’s Helping to End Addiction Long-term (HEAL) initiative to speed scientific solutions to the national opioid public health crisis. The NIH HEAL Initiative will bolster research across NIH to (1) improve treatment for opioid misuse and addiction and (2) enhance pain management. This broad research effort seeks to improve pain care through understanding the development of chronic pain and by accelerating and improving the process of therapy development to more rapidly move discoveries into clinical practice to alleviate the burden of pain. More information about the HEAL Initiative is available at: https://www.nih.gov/research-training/medical-research-initiatives/heal-initiative.


    Process for Identifying Additional Sites

    • Determine number of participants to be enrolled.
    • Determine number of potential participants at applicant’s institution and institutions of any co-investigators.
    • Identify HEAL Point of Contacts (POC) at individual CTSA hubs to determine size of potential cohorts (see trialinnovationnetwork.org or contact emily.p.paku@medstar.net who can facilitate this process).
    • Determine whether CTSA hub wishes to participate in the trial (see next slide) and ask for a letter of intent for application.

    Trial Innovation Network (TIN) Resources 

    TIN will provide these resources to all awardees (no letter of support needed): 

    • Single IRB services for the trial; 
    • Assistance with execution of the Master Clinical Trial Agreements with clinical sites; 
    • Developing final study protocol with study team; 
    • Finalizing recruitment and retention plans with investigators before trial initiation; 
    • Providing support for study design, statistical analyses and interpretation of results for manuscripts and publications; 
    • Developing associated trial documents, e.g., 
      • Manual of Procedures 
      • Standard Operating Procedures 
      • Case report forms 
      • Training materials for study personnel 
    • Training clinical site investigators and staff for individual trials.
      • Training areas include, but are not limited to, regulatory requirements, Good Clinical Practice (GCP), adverse event reporting, human subject protections, informed consent, and NIH policies and procedures
    Budget

    Estimated Total Funding: $800,000 total costs for FY2020; $2,000,000 total costs per year for FY2021, FY2022, FY2023, FY2024
    Expected Number of Awards: 2

    Estimated Award Ceiling: Up to $500,000 direct cost for the one-year UG3 phase and up to $1,000,000 per year direct cost for the UH3 phase for no more than 4 years. Note that the Trial Innovation Network will provide infrastructure including the data management system, clinical coordination, and support for trial document development such as the manual of procedures. These costs should not be included in the UG3/UH3 budgets.

    Note that the Trial Innovation Network will provide infrastructure including the data management system, clinical coordination, and support for trial document development such as the manual of procedures. These costs should not be included in the UG3/UH3 budgets.
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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