Trial Innovation Network: Learning and Growing

Since its launch in October of 2016, the Trial Innovation Network has approved 21 of 33 submitted proposals for services or consultations on clinical trials, and has refined its proposal submission process. Depending on the outcome of the 16 consultations currently underway, these clinical trials may be implemented through the network starting in early 2018.

The Trial Innovation Network is a large, national clinical trial network that leverages the expertise and resources of the 64 institutions funded by the Clinical and Translational Science Award (CTSA) Program.  The network provides infrastructure and serves as a national laboratory to study and to refine the process of conducting large, multisite clinical trials.

Full time faculty at the primary institution of a CTSA Hub, such as the University of Rochester Medical Center, can submit proposals to the Trial Innovation Network at any time. Below is a detailed description of the new proposal submission process.

Before submitting a proposal to the network:

• Contact ResearchHelp@urmc.rochester.edu to set up a preliminary consultation with the CTSI Trial Innovation Network liaison team and to obtain approval from one of the CTSI directors, Martin Zand, M.D., Ph.D., or Nancy Bennett, M.D.
• Contact the National Institutes of Health program officer of the institute or center funding the study or where funding will be sought. The program officer must indicate that the study is appropriate for funding from their institute as well as for submission to the Trial Innovation Network.

Apply for Trial Services:

• Trial services include operationalizing a Central Institutional Review Board (cIRB) and standard agreements, develop a recruitment plan and materials, assess feasibility of the study and recruitment strategy, and conduct patient engagement studios.
• Full time faculty who have already applied and/or received funding for a clinical study
  • Indicate that the study proposal has already undergone scientific peer review
  • Indicate the amount of funding awarded (or amount proposed)
  • Provide letter of approval from the CTSI director
  • Provide NIH program officer name on proposal form
  • Submit a proposal for Trial Service

Apply for Trial Consultations:

• Helps investigators design the study protocol, 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.
• Full time faculty with a study in the development phase (not yet funded)
  • Include details or plan for scientific peer review such as reviewing organization, review process, and a timeline for reviews that are planned, but not yet completed
  • Provide funding plans including an estimated budget and NIH granting mechanism, if appropriate
  • Provide letter of approval from the CTSI director
  • Provide the name of the NIH program officer consulted
  • Submit a proposal for Trial Consultation

Trial Implementation:

• Provide a standard agreement, cIRB, recruitment sites, regulatory support, project management, training and performance assessment, enrollment metrics, aid with development of consent forms, site selection and trial initiation at those sites, recruitment plans and tools, data management that meets Data and Safety Monitoring Board guidelines, statistical analysis, the study close out process, and publications.
• Investigators whose clinical trials are deemed appropriate may apply for a comprehensive consultation, which may lead to implementation through the network.    

As the Trial Innovation Network develops, these processes are subject to change. For the most up-to-date information, keep an eye on trialinnovationnetwork.org. 

Michael Hazard | 3/2/2017