Trial Innovation Network Resources
The Trial Innovation Network is a rapidly developing and evolving new collaborative initiative of the CTSA Program that leverages the expertise, skills, and knowledge of the entire CTSA Consortium. The Trial Innovation Network is composed of three key organizational partners – the Trial Innovation Centers (TICs), the Recruitment Innovation Center (RIC), and the CTSA Program Hubs.
Trial Innovation Center (TIC)
Recruitment Innovation Center (RIC)
Trial Innovation Network Liaison Team
- Can you provide a timeline for setting up the CTSA Hub teams – what do you need from the Hubs and by when?
- CTSA Hubs were encouraged to begin to establish their Network Hub Liaison Teams by December 10, 2016. We have collected a roster of team members from the CTSA PIs or designee through this survey.
- We encourage the CTSA Hubs to organize their Liaison Teams as soon as possible. The Hub Liaison Teams should include a Medical Director and key staff to operationalize the key elements of the Trial Innovation Network – the Central IRB, standard agreements, and recruitment efforts. The Hub Liaison Team should also include key staff who can assist in disseminating information about the Trial Innovation Network.
- What are the responsibilities of the CTSA Program PIs and Trial Innovation Network Hub Liaison Teams?
- Sharing information about the Trial Innovation Network and educating their Hubs about the Network
- Operationalizing the key elements of the Trial Innovation Network including
- Central IRB
- Standard Agreements
- Recruitment Efforts
- In the future, the Hub Liaison Teams will also be responsible for assisting in Trial Innovation Network clinical trials
- Could you please clarify the role and qualifications of the Trial Innovation Network Medical Director? What are the types of activities for which he will be responsible?
- General qualifications of Trial Innovation Network Hub Liaison Team Medical Director:
- Experienced in clinical trials
- Expertise in trial start-up, enrollment, data quality, GCP, local IRB and contracting process, human subjects research
- Experienced in leading and managing research teams
- Experienced in the use of performance metrics
- Role and Responsibilities of the Trial Innovation Network Hub Liaison Team Medical Director:
- Leader of Network Hub Liaison Team
- Communicates with CTSA PI about the Trial Innovation Network
- Leads strategic planning, administration, and operations of Network Hub Liaison team
- Communicates Trial Innovation Network mission, goals, and objectives to Hub investigators and Institutional leadership
- Works collaboratively with CTSA Hub PI to implement Trial Innovation Network clinical trials
- Identifies and collaborates with CTSA Hub Network Trial-Specific PIs
- Network Hub Liaison Team point of contact for TICs, RIC, and NCATS
- General qualifications of Trial Innovation Network Hub Liaison Team Medical Director:
- Do partner institutions to a Hub, need to adopt the Standard Agreement and SmartIRB reliance agreements in order to participate, since they are a separate institution?
- Yes, any Institution that might be involved in a Network study should be willing to adopt the Network Agreements (CIRB and Standard Agreement)
Collaboration with NIH Institutes and other Networks
- How will NCATS engage other NIH Institutes in the Trial Innovation Network?
- NCATS is making dedicated efforts to disseminate information about the Trial Innovation Network through presentations and discussions with NIH Institutes. NCATS would like to invite the CTSA PIs to join in the effort by encouraging them, in their role as leaders, to be ambassadors of the CTSA Program and share information about the Trial Innovation Network with NIH Institutes and Hub Investigators.
- The Network Projects, which involve partnerships with other Institutes, will offer additional opportunities to collaborate with other NIH Institutes and share information about the Network.
- There are existing CTSA Program networks (e.g., MARCH). How does NCATS see the Trial Innovation Networks interfacing with these?
- The Trial Innovation Network looks forward to learning from existing CTSA Program Networks and invites representatives from current programs to contact the TIC and RIC PIs and NCATS staff to begin a dialogue on ideas for collaboration.
- How does the Trial Innovation Network relate to other NIH Networks?
- The Trial Innovation Network is designed to be a complementary resource for investigators and NIH Institutes and can work in partnership with other NIH Networks. The program staff of other NIH networks should contact NCATS staff to discuss how best to collaborate.
Operationalizing the Standard Agreement for the Trial Innovation Network
- What if some of the sites think the Standard Agreement will work, but some find that it will not fit?
- The Trial Innovation Network Standard Agreement template (FDP-CTSA) is an agreement that has been reviewed and agreed upon by over 25 CTSA Institutions. It is intended to be a starting point for each Institution involved in a Trial Innovation Network Study. This sample agreement can be adjusted if absolutely necessary for a particular Institution.
- Is budget negotiation part of the Trial Innovation Network Standard Agreement template (FDP-CTSA) or separate?
- Budget negotiation is separate from the negotiation about the Standard Agreement template.
Metrics, Data and Dashboards
- Will there be any uniform platform for conduct of trials within the network –e.g., data capture, monitoring of enrollment, AE’s etc.? Will the Trial Innovation Network eventually include other aspects of the other NIH cooperative groups, like central storing of data and samples and common data coordination?
- The Trial Innovation Network is first focusing on developing the key elements of the Network – the CIRB, standard agreements, and recruitment efforts. As the Network progresses, we will develop plans to harmonize other aspects of clinical trial management.
- Will the TICs support a PO1 grant, it being a general support grant as opposed to specific trial focused application?
- The Trial Innovation Network is designed to provide support to clinical trials and studies, and is not intended to provide a supplement to an administrative core of a P01 grant.
- Is it possible to get a better idea of what the services can provide? It's difficult for us to know what services our investigators could benefit from as we offer many of the services locally that seem to be provided through the TIN.
- Please see the updated information on the Trial Innovation Network website describing proposals requesting Services and Initial Consultations.
- Is the proposal review process ongoing/rolling and what are the expected timelines of review?
- Proposals are being reviewed on a rolling basis and the current timeframe from submission of review to distribution of a decision letter is approximately 4-6 weeks.
- What type of studies should be submitted?
- The Trial Innovation Network is a platform for multi-center trials and studies that encompass a wide-range of disciplines. Investigators do not need to apply for a specific RFA, but should propose a multi-center trial or study. The Network will prioritize proposals for multi-center clinical trials and studies with patient-oriented endpoints with potential for impact on clinical practice and operational innovation as well as proposals that foster collaborations with other NIH ICs over proposals seeking funding from NCATS.
- Is the expectation that if local resources are sufficient no proposal will be submitted to the Network?
- Investigators are requested to first leverage local CTSA Program resources, particularly for protocol design and statistical plans, before submitting a proposal to the Trial Innovation Network, however if additional resources are necessary and are aligned with the work of the Network a proposal could be appropriate.
- Does the "Initial Consult" always include all the elements of the initial consults Feasibility, budget, timeline etc?
- The Initial Consultation is expected to consist of 8-10 hours of consult time. It is anticipated that the research team might narrow the selection to the top 3 priorities to optimize the consult for their needs.
- When the CTSA PI "approves" the study is that an endorsement of the proposal or is it acknowledgement of the proposal being submitted? Is the Hub meant to be a first line of official review?
- The goal of asking a CTSA Hub PI to review and approve a proposal is to ensure that the Hub PI is aware of all proposals submitted to the Trial Innovation Network by their Hub. This also gives the Hub PI an opportunity to discuss the proposal with the investigator and encourage him to leverage local resources.
- Can a consultation be conducted at the same time that the proposal is submitted to NIH, or does it need to be done prior to submitting the proposal?
- An initial consultation should occur prior to an application being submitted to an NIH Institute for funding.
Content Updates Pending
TRIAL INNOVATION NETWORK – NOW ACCEPTING NETWORK PROPOSALS!
- Proposals are now being accepted on a rolling basis.
SUBMITTING A NETWORK PROJECT PROPOSAL
Encourage investigators to:
- Contact their NIH Program Director
- To confirm your project is within the scope of the IC's mission
- To confirm TIC assistance is allowed by your funding mechanism
- Speak with their CTSA Program Hub PI and Trial Innovation Network Hub Liaison Team
- The local teams can provide assistance in developing your study protocol
- Review the Trial Innovation website https://trialinnovationnetwork.org
- Submit questions to: email@example.com
HOW ARE PROPOSALS BEING EVALUATED?
- Is the proposal complete? (all information requested is provided)
- Is the proposal within the scope of the NIH, The Trial Innovation Network, and specific NIH Institute?
- Has the investigator contacted the CTSA Hub PI/Trial Innovation Network Liaison Team and NIH IC Program Officer
- Is the proposal for a multi-center trial or study?
- Is the investigator a PI at a CTSA Program Hub or Partner (A partner is defined as an Institution receiving a sub-award on the CTSA award)
- Does the proposal have a strong scientific hypothesis?
- Is the proposal operationally feasible?
- Does the proposal have potential for operational innovation?
- Can the Trial Innovation Network to execute services at its current stage?
- What level of resources is required?
WHAT ARE THE NEXT STEPS FOR TRIAL INNOVATION NETWORK HUB LIAISON TEAMS?
- Review the Trial Innovation Network website and application process
- Encourage the local investigators to do the same
- Reach Out
- Disseminate information about the Trial Innovation Network to local investigators
- Conduct grand rounds, host informal talks, distribute slide set, send regular updates via email
- Stay In Touch
- Contact the Trial Innovation Network at firstname.lastname@example.org with any questions
- A team of Project Leaders are ready and eager to assist with any questions
(Update Pending) Trial Innovation Network Hub Liaison Teams - A Proposed Framework
Trial Innovation Network Team Roster
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