Trial Innovation Network Hub Liaison Teams A Proposed Framework

Goals:

·  The Trial Innovation Network aims to be a novel and disruptive model for multi-center clinical trials in which stakeholders who make essential contributions are engaged early in the research process and recognized as key partners.

·  The key organizational partners of the Trial Innovation Network are:

o  the Trial Innovation Centers

o  the Recruitment Innovation Center

o  the CTSA Hubs

o  NCATS and NIH Institutes and Centers

·  As key partners of the Trial Innovation Network, the CTSA Program Hubs play integral roles by:

o  Encouraging investigators at their Institutions to generate ideas for for multi-center trials and studies that encompass a wide-range of disciplines Providing input before protocols are implemented

o  Encouraging investigators to taking advantage of existing CTSA resources

o  Recognizing the essential contributions and efforts of their local teams in executing multi-center clinical trials

o  Creating a culture in which key stakeholders play unique and important roles

o  Work together to build a national system to conduct clinical trials better, faster, and more cost-effectively

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The multi-disciplinary Trial Innovation Network Hub Liaison Teams will facilitate and lead scientific, training, and implementation aspects of the Trial Innovation Network in collaboration with the scientific. They will 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. A proposed list of key roles and responsibilities of the Trial Innovation Network Hub Liaison Teams is summarized in the Table below.

As the Trial Innovation Network evolves, the roles and responsibilities of the Trial Innovation Network Hub Liaison Teams will also evolve. For that reason, we will proceed in stages. At this early time, the focus will be on building the key elements of the Network.

The Hub Liaison Team will function as an interface between the TICs and RIC and the CTSA Hubs. Responsibilities related to the Trial Innovation Network are outlined below, but roles and responsibilities of the Hub Liaison Teams may evolve as the Trial Innovation Network further develops. CTSA Program Hubs do not have to identify all members of the Hub Liaison Team now, but should be flexible as the plans for Hub Liaison Teams evolve.

A proposed structure for the Hub Liaison Team includes a scientific lead, who should be an experienced researcher with an advanced clinical scientific degree, and an operational lead, who should be a research professional with experience and skills to administer and organize the Hub Liaison Team. In addition, the Hub Liaison Team should plan to include research staff with knowledge of local resources for research, and expertise in working with investigators, IRB, contracting, clinical operations, and IT/informatics.

Opportunities, Roles and Responsibilities of the Trial Innovation Network Hub Liaison Teams

Trial Innovation Network
CTSA Program Hubs – Key Partners in Science and Training
Opportunity
Partners in Science / Trial Innovation Network Hub Liaison Team Roles and Responsibilities
The CTSA Program Hubs will lead science in the Trial Innovation Network / Develop the Trial Innovation Network as a resource for local investigators and faculty. The Trial Innovation Network Hub Liaison Team should:
·  Encourage investigators/faculty to submit Network Project proposals to the Trial Innovation Network
·  Encourage investigators/faculty to leverage the Trial Innovation Network as a resource to develop proposals into protocols and potential clinical trials
·  Encourage investigators/faculty to share information about the Trial Innovation Network with NIH Institutes, industry, and other potential stakeholders
·  Review and provide feedback on protocols that may be developed into future clinical trials supported by the Trial Innovation Network
Opportunity
Partners in Training / Trial Innovation Network Hub Liaison Team Roles and Responsibilities
The CTSA Program Hubs will lead training of their Trial Innovation Network Hub Liaison Teams and will disseminate the training/educational tools developed by the CTSA Program / Create a national clinical trials workforce and develop a poised research team ready to implement trials and studies at the highest level of quality. The Trial Innovation Network Hub Liaison Teams should:
·  Use the Network to provide hands on, practical training in clinical trials for investigators/faculty/research staff
·  Ensure Network Hub Liaison Teams and study teams are trained in Good Clinical Practice, fundamentals of clinical trials, community engagement, bioinformatics, etc.
·  Educate study teams in best practices for study administration and disseminate training/educational tools developed by the CTSA Program
Trial Innovation Network
CTSA Program Hubs – Key Partners in Organizing the Network and Executing Trials
Opportunity
Partners in Organizing the Network / Trial Innovation Network Hub Liaison Team Roles and Responsibilities
Establish a Trial Innovation Network Hub Liaison Team / Build the Trial Innovation Network by organizing the Trial Innovation Network Hub Liaison Teams and developing key elements of the Network. The Trial Innovation Network Hub Liaison Teams will:
·  Operationalize the Trial Innovation Network at the Hub level
·  Serve as the primary point of contact between the CTSA Program Hub and the TICs and RIC
·  Engage the Hub Institutions as stakeholders and leverage local resources, knowledge, and expertise
·  Operationalize and execute Network Projects and Trials at the highest level of quality
·  Educate CTSA Program Hub investigators and study teams about Trial Innovation Network resources
·  Organize regular Trial Innovation Network Hub Liaison Team meetings with CTSA Program Hub leadership to establish local goals, encourage ideas from investigators/faculty, and identify areas for innovation
·  Develop good working relationships with local researchers
Build a harmonized Standard Agreements system in the Trial Innovation Network / Build a system for harmonized Standard Agreements in the Trial Innovation Network by:
·  Working with the TICs and local study teams to operationalize the FDP-CTSA Master Agreement Template in Network Projects and Trials
·  Monitoring and addressing issues that arise with the FDP-CTSA Master Agreement revisions and amendments to ensure timely execution
Build a harmonized Central IRB system in the Trial Innovation Network / Build a harmonized Central IRB system in the Trial Innovation Network by:
·  Working with the TICs and local study teams to operationalize the Trial Innovation Network Central IRBs in Network Projects and Trials
·  Functioning as the Point of Contact with Trial Innovation Center (TIC) Central IRBs to obtain IRB approval and manage the IRB regulatory review process.
·  Working with local study teams to obtain information to facilitate the Central IRB review.
·  Addressing barriers at the local level related to Central IRB review such as management of COI and training requirements for study team members
Build Capacity for Future Recruitment / Build capacity for future recruitment activities in the Trial Innovation Network by:
·  Promoting best practices for recruitment
·  Assessing feasibility of local recruitment strategies and ensuring local recruitment plans and teams are in place
·  Ensuring appropriate IT expertise and resources are available to support recruitment activities
·  Ensuring good team coordination and communication with study coordinators, community engagement specialists, and marketing colleagues

·  Raising awareness and educating the public in research including opportunities to be involved in Trial Innovation Network trials.
·  Ensuring there is an accessible and central point where potential participants can learn how to become involved in clinical trials
·  Functioning as the Point of Contact for the RIC for recruitment issues. Knowing when to contact the RIC for additional support for Trial Innovation Network trials.
·  Encouraging use of RIC tools, resources, and services locally
·  Participating in and helping to develop RIC webinars
Participate in Developing Future Protocols / Participate in developing future protocols for the Trial Innovation Network by:
·  Reviewing and providing input on the scientific value and feasibility of protocols that may later be implemented in the Trial Innovation Network.
·  Providing feedback on proposed study budgets during protocol review stage