The Irving Institute is currently accepting applications for the following:

TL1 Training Program for Doctoral Students and Postdoctoral Appointees For Immediate Start and 2018-2019
TRx Pre-Proposals Apply by December 1

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The vision for the Trial Innovation Network is to innovatively address critical roadblocks in clinical trials and accelerate the translation of novel interventions into life-saving therapies.

The goal of the Trial Innovation Network is not only to execute trials better, faster, and more cost-efficiently but, importantly, to be a national laboratory to study, understand, and innovate the process of conducting clinical trials.

Overview

At Columbia University Medical Center, we have a Trial Innovation Network (TIN) Hub Liaison Team. The goal of the TIN Hub Liaison Team is to help Columbia clinical trialists and investigators develop, fund, and implement clinical trials in the most efficient manner.

The goals of the Trial Innovation Network are

  • to help trialists and investigators get their trials developed, funded, and implemented
  • to provide assistance and consultation on all aspects of study design and implementation
  • to execute trials better, faster, and more cost-efficiently
  • to be a national laboratory to study, understand, and innovate the process of conducting clinical trials

The Trial Innovation Network is a collaborative national network that will leverage the expertise and resources of the CTSA Program and focus on

  • operational innovation
  • operational excellence
  • collaboration

The Trial Innovation Network will feature

  • opportunities for local and national review and expert input on all aspects of trial design
  • a single IRB system
  • master contracting agreements
  • optimal approaches to study design
  • a focus on evidence-based strategies for recruitment and patient engagement

The Trial Innovation Network consists of

  • the CTSA Program Hubs
  • three national Trial Innovation Centers (TICs)
  • a national Recruitment Innovation Center (RIC)

Our role in the Trial Innovation Network

As key partners of the Trial Innovation Network, the CUMC CTSA Program Hub plays an integral role by

  • Encouraging faculty and investigators to generate ideas for trials
  • Providing input before protocols are submitted to the TIN and to NIH for funding
  • Recognizing the essential contributions and efforts of local teams in executing multi-center clinical trials
  • Creating a culture in which key stakeholders play unique and important roles, and help to build a national system to conduct clinical trials better, faster, and more cost-effectively

The Irving Institute's TIN Hub Liaison Team (any questions please contact Linda Busacca)


Muredach Reilly, MB, MS
Irving Institute Director and PI
mpr2144@cumc.columbia.edu

Mitchell Elkind, MD
Medical Director
mse13@cumc.columbia.edu

Soumitra Sengupta, PhD
Director of Informatics
ss29@cumc.columbia.edu

Linda Busacca
Project Manager
lb103@cumc.columbia.edu

Ying Cheung, PhD
Biostatistics Specialist yc632@cumc.columbia.edu

Alan Teller
IRB Specialist
at2059@cumc.columbia.edu

Rudi Odeh-Ramadan, PharmD
Contract Specialist
ro133@cumc.columbia.edu

Helen Kim, PharmD
Contract Specialist
hk2580@cumc.columbia.edu

Our Collaborators

The Trial Innovation Network is a collaborative partnership among the Trial Innovation Centers (TICs), the Recruitment Innovation Center (RIC), and the CTSA Program Hubs (through their Trial Innovation Network Hub Liaison Teams).

Explanation of the Trial Innovation Center (TIC) and Recruitment Innovation Center (RIC)

A TIC is a Trial Innovation Center, funded by National Center for Advancing Translational Sciences (NCATS) to streamline the processes of research. The TICs are Duke/Vanderbilt; University of Utah; and Johns Hopkins/Tufts.

Vanderbilt is also the Recruitment Innovation Center (RIC), specializing in the development and consolidation of electronic methods for facilitating recruitment.

The 3 TICs and the RIC

The Trial Innovation Network (TIN) Offers two levels of project assistance

Level 1

Network Projects

The TIN will provide these Basic Services and Consultations

  • Operationalize Master Agreements
  • Operationalize Single IRB
  • Patient Engagement Studio
  • Recruitment Feasibility Assessment
  • Recruitment Materials (Standard Tools)
  • Recruitment Planning Consultation
  • Study Design Consultation
  • Study Budget Consultation
  • Site Identification Consultation

Key Steps

Level 2

Network Projects

The TIN will provide Comprehensive Consultation - Investigators work with TICs/RIC to develop a proposal into a Trial Innovation Network proposal.

Protocol Development and Potential Trial Implementation

    1. Development of Protocol

  • Project Planning
  • Development of Study and Site Budgets
  • Site Selection/Assessments
  • Data Safety and Monitoring Plan
  • Statistical Analysis
  • Risk Based Monitoring
  • Regulatory Support for FDA Submission
  • Development of Recruitment Plan/Feasibility Assessment/Informatics Tool Consultation Recruitment Training

    2. Trial Implementation

  • If study funded, potential implementation of clinical trial

Key Points

  • Investigators have access to operational and recruitment experts
  • Protocols vetted with potential CTSA Hubs before funding decisions
  • If TICs/RIC used as Coordinating Centers, NCATS will provide infrastructure/resources up to a pre-specified threshold

Key Steps

How to use the Trial Innovation Network

  • Review the details about trial concept submission on the TIN website, http://trialinnovationnetwork.org
  • Make an appointment to speak with the Hub Liaison Team (contact Linda Busacca lb103@cumc.columbia.edu )
  • Instructions on how to submit a proposal submission form can be found on the TIN website. Submissions must be made using the on-line form at http://trialinnovationnetwork.org/services/submit-a-proposal.

  • After you submit a proposal, 3 steps happen:
    • Administrative Review - Ensure proposal form is complete
    • NCATS Review - Ensure proposal aligned with NIH mission, check of scientific and budgetary overlap, ensure communication with other NIH ICs
    • PAT (Proposal Assessment Team) Review - Assess study feasibility, alignment with goals of Network, ability to support with current resources

  • After your proposal has been assessed, the Trial Innovation Network will notify the Hub Liaison Team, who will notify you.
  • Contact Linda Busacca lb103@cumc.columbia.edu with questions or for additional information.