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July 31, 2017

New CTSA Program Initiative: Trial Innovation Network
By Donna Brassil, MA, RN, CCRC

The Trial Innovation Network is a CTSA program that leverages the expertise, skills, and knowledge of the entire CTSA Consortium. It is composed of three key organizational partners – the CTSA Program Hubs, the Trial Innovation Centers (TICs), and the Recruitment Innovation Center (RIC). Each partner plays a unique and essential role.

The vision for the TIN is to creatively address critical roadblocks in clinical trial development and conduct, and thus accelerate the translation of novel interventions into life-saving therapies. The TIN focuses on operational innovation, operational excellence, and collaboration. It features a single IRB system, master contracting agreements, quality by design approaches, and evidence-based strategies to recruitment and patient engagement. The TIN will also be a national laboratory to study, understand, and innovate the process of conducting clinical trials.

The Rockefeller University Trial Innovation Network (TIN) Hub Liaison Team

At Rockefeller University, we have a TIN Hub Liaison Team. The goal of the team is to help investigators develop and implement clinical trials in the most efficient manner.

• Providing input/Navigation before protocols are submitted to the TIN.

• 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 CTSA Program Hubs are the frontline of the TIN. They 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 Rockefeller University TIN Hub Liaison Team is comprised of Barry Coller, James Krueger, Barbara O’Sullivan, Rhonda Kost, Maija Neville-Williams, Teresa Solomon, Vanessa Smith, and Donna Brassil.

Trial Innovation Center (TIC) and Recruitment Innovation Center (RIC)

The TICs are located at Duke/Vanderbilt, University of Utah, and Johns Hopkins/Tufts. They are charged with streamlining the TIN’s procedures.

There is one Recruitment Innovation Center (RIC) at Vanderbilt and it specializes in the development and consolidation of electronic methods for facilitating recruitment.


Investigators can request consultations and services for multi-center clinical trials and studies from the TIN from a menu of choices. Some consultations may lead to further development into full clinical protocols that may be implemented in the TIN.

Services Offered

The TIN first offers an initial consultation or specific service depending on the funding status of the proposal. Investigators are invited to submit proposals to the TIN at any time.

For Studies that Already Have Funding or Have Already Applied for Funding:

Trial Innovation Network Services: Service requests are prioritized based on resource availability. Specific services include Standard Agreement and Central IRB Operationalization, Recruitment Materials and a Recruitment Plan, a Community Engagement Studio, and an EHR -Based Cohort Assessment.

For Studies that are Still Under Development and Have Not Yet Been Funded:

Trial Innovation Network Initial Consultation

• An initial consultation may include, for example, study design, budget recommendations, a proposed timeline, recruitment assessment, and study feasibility assessment.

Trial Innovation Network Comprehensive Consultation

• Based on the outcome of an Initial Consultation, the next step may be a Comprehensive Consultation. A Comprehensive Consultation cannot be selected by an investigator, but is a decision that is reached by the TIN after the Initial Consultation and after approval by the Proposal Assessment Team and NCATS.

• A Comprehensive Consultation involves mutual agreement and commitment by the investigator and the TIC/RIC to collaboratively develop the proposal into a protocol. In addition, one of the goals in the Comprehensive Consultation process is to obtain input from the CTSA Hubs on the protocol. The estimated number of hours of consultation time for a Comprehensive Consultation has not yet been determined.

• A Comprehensive Consultation could include an array of enhanced consultations such as in-depth protocol development, statistics, recruitment feasibility, recruitment plans, study budgets, and other key elements.

• After a Comprehensive Consultation, an investigator prepares a clinical trial application for submission to an NIH Institute for funding or to an industry or philanthropic partner. The TICs and RIC would serve as the Coordinating Centers for the study and the CTSA Hubs would be potential sites.

For detailed information on the TIN process and guidelines, log onto the toolbox at https://trialinnovationnetwork.org/elements/trial-innovation-network-proposal-process/

Prior to submitting a TIN Project Proposal, investigators must discuss the proposal with his/her CTSA Program Hub Principal Investigator and the TIN Liaison Team, so feel free to speak to any of us about your interest.