Trial Innovation Network
The Trial Innovation Network connects CTSA Program Hubs nationwide to leverage their expertise and resources to conduct large, multi-site clinical trials. The goals of the network are (1) to execute trials better, faster, and more cost-efficiently, and (2) to be a national laboratory to study, understand and innovate the process of conducting clinical trials.
The Trial Innovation Network features a single IRB reliance model (also known as the SMART IRB), master contract agreements, quality by design approaches, and a focus on evidence-based strategies for participant recruitment and patient engagement.
The UR CTSI recommends that UR researchers who are planning to conduct a multi-site study review the OHSP Guideline for Principal Investigator Oversight for Multi-Site Research under OHSP Policy 504 as well as the RSRB fee structure before submitting their application to the UR RSRB as the reviewing IRB.
The UR CTSI has a hub liaison team which is made of members from the UR CTSI and the UR Office of Human Subject Protection. This team will provide support for all interactions with the network. To arrange a meeting with the hub team, contact the UR CTSI Research Help Desk.
Participate in the Network
Since the UR CTSI is a hub in the national CTSA Consortium, UR Researchers can participate in the Trial Innovation Network.
- UR Researchers can submit projects to be conducted using the network. Researchers can submit proposals for Services or Consultations for their clinical trials through the Trial Innovation Network website. Before submitting a proposal, faculty must meet with the UR CTSI Trial Innovation Network liaison team and obtain approval from one of the UR CTSI Directors. Contact the UR CTSI Research Help Desk to set up a meeting with our liaisons.
- UR Researchers can participate as a site in multi-site clinical trials initiated by others in the network. Researchers may also take advantage of consultation services provided by the Network’s Trial Innovation Centers and Recruitment Innovation Center.
Clinical Trial Consultations
- Full-time faculty with a study in the development phase (not yet funded) may apply for clinical trial consultations.
- Clinical trial consultations help investigators design the protocol for their study, determine study and recruitment plan feasibility, set a budget, develop a statistical analysis plan, assess study risk, and provide phenotype based cohort counts and recruitment training.
- Depending on the outcome of the initial consultation, a clinical trial may be recommended for a comprehensive consultation, which could ultimately result in the full implementation of the clinical trial through the Trial Innovation Network.
Proposals will be evaluated by the network for feasibility, potential for operational innovation, resource requirement, and ability of the Trial Innovation Network to deliver services/consultations. Approved proposals will be assigned to a Trial Innovation Center (Duke University, University of Utah, or Johns Hopkins University) or the Recruitment Innovation Center (Vanderbilt University) and services/consultations will be provided after decisions are made.
If you have questions or would like to submit a proposal to the network, please contact our Trial Innovation Network liaison team by contacting the UR CTSI Research Help Desk.
Clinical Trial Implementation Services
Full-time faculty who have already applied and/or received funding for a clinical study may apply for clinical trial services.
Clinical trial implementation services include operationalizing a Central Institutional Review Board and standard agreements, developing a recruitment plan and materials, assessing feasibility of the study and recruitment strategy, and conducting patient engagement studios.
Attend or Host a Trial Innovation Network Webinar
Learn about clinical trial best practices and lessons learned from experts around the country through Trial Innovation Network webinars and forums. All University of Rochester and URMC faculty, staff and trainees are welcome to attend these webinars and can even host their own Collaboration Webinar. If you are interested in sharing your expertise, methods and/or best practices to improve the way trials are conducted, submit a ticket to the UR CTSI Research Help Desk to discuss your webinar proposal with URMC Trial Innovation Network liaisons.