Trial Innovation Network provides resources for investigators

UB researchers seeking feedback, ideas and resources focused on carrying out multicenter clinical trials in a better, faster and more cost-efficient manner have access to the Trial Innovation Network (TIN), a unique collaborative initiative of the National Institutes of Health (NIH) National Center for Advancing Translational Sciences (NCATS) and the Clinical and Translational Science Award (CTSA) program.

NCATS launched TIN in 2016 to help researchers speed up the translation of new breakthroughs and interventions into life-saving strategies used in clinical settings. Its mission:

• Leverage the talent, expertise and resources of the CTSA program.
• Act as a national laboratory to study, understand and improve multisite trials.
• Inform health care by supporting successful multisite trials that answer important clinical questions.

Sanjay Sethi, assistant vice president for health sciences and associate director, Clinical and Translational Science Institute (CTSI) calls TIN “an important tool for investigators seeking to develop and implement innovative, collaborative solutions in an effort to transform clinical and translational research.”

TIN offers investigators the opportunity to request consultations and resources for multicenter clinical trials and studies across disciplines and disease areas. Types of support offered include:

• Initial consultation: All proposals accepted into the TIN portal are provided with an initial consultation.
• Resources: Requests for additional resources are put forward for internal approval.
• Comprehensive consultation: The investigator and TIN work together to develop and submit a proposal.
• Trial implementation: The TIN serves as the trial data or clinical coordinating center.

“TIN provides an opportunity to use the resources and experience available at 50-plus CTSAs across the United States,” says Sethi. “If a UB investigator has a multisite proposal that is in the planning phase, the TIN can provide a proposal review that can greatly enhance the quality of the proposal and increase its probability of funding. If the local investigator has a funded proposal, the TIN can be used to find sites to conduct the study within the CTSA consortium.”

Larry Hawk, professor in the Department of Psychology and CTSI creative scientist workshops director, says TIN can facilitate a variety of aspects of clinical trials and, in particular, multisite trials.

“It is a great resource on a number of topics,” Hawk says. “Timing is key because as with any type of collaboration, it takes a while to develop and finalize.” The timeline is why he advises investigators to “start early, so you can consider the impact on the content of the proposal, but also the potential impact on budgeting for those additional resources.”

Ashley Regling, CTSI clinical recruitment coordinator, says another reason to start early is to take advantage of the TIN single Institutional Review Board (IRB) option. “Including the TIN single IRB option in the study budget will allow for TIN staff members to coordinate all aspects of the IRB process associated with the multisite study,” Regling explains. “This can save principal investigators and study team members a lot of time and effort during the study startup process and as continuing IRB reviews are due.”

Catherine Wrona, a clinical research coordinator in UB’s Clinical Research Office, is the coordinator for a convalescent plasma study that utilized TIN.

“TIN made a positive difference for our study,” Wrona says. “Having a core group for centralizing regulatory, IRB, contracts and study activation allowed us to enroll patients in a short period of time.”

TIN offers free webinars and events. Next on the schedule is “Inclusion of Individuals With Intellectual and Developmental Disabilities in Research: Opportunities and Challenges” on March 7. Previous sessions are archived on the TIN website.

“One of the best things about the Trial Innovation Network is that it allows people from CTSAs to share solutions to problems that sometimes hinder collaborative research,” says Alexis O'Brien, CTSI clinical research facilitator. “At TIN events, you learn about solutions you can implement for research at UB, or tools that other institutions have developed and are sharing with their fellow CTSA institutions.”

The “TIN Toolbox” is a helpful resource that contains free resources for research teams. The resources are available for download and can be adapted to aid in study recruitment and retention efforts.

TIN is utilized across the CTSA consortium. As of January 2022, 358 total proposals were submitted, with 72 therapeutic areas represented, 60 CTSAs submitting proposals and 20 NIH institutes and centers being engaged.

“In addition to informative presentations, the TIN sends potential collaborative research opportunities through a TIN-developed outreach model,” O’Brien says. “The TIN then hosts investigator-led webinars in which lead investigators discuss their upcoming studies and answer potential collaborators’ questions. Researchers who have been contacted about opportunities are encouraged to attend these webinars.”

To get started with TIN, investigators are advised to spend some time reviewing the TIN website, particularly the “Frequently Asked Questions,” and then reach out to one or both of the CTSI’s TIN liaisons — O’Brien and Regling.

O’Brien says researchers who have developed their own proposal for a multisite study and have identified a potential source of funding can contact the TIN directly to schedule an initial consultation after discussing their proposal with the CTSA principal investigator and a UB CTSI TIN liaison.

“The researcher can invite collaborators and other experts familiar with the project to the consultation,” O’Brien adds. “The TIN will be sure to invite the UB CTSI TIN liaisons to the consultation as well.”

Regling points out that “there is no cost associated with an initial consultation, which includes things like budget assessment and assistance with study design. Therefore, it makes sense for interested investigators to at least take that first step and contact TIN for an initial consultation.”

Hawk agrees. “I would say, especially if you are going to write a proposal to NCATS, you should at least do the consultation in order to engage with the Trial Innovation Network and its resources. In my experience, it was very helpful.”

To learn more about TIN, contact UB's Trial Innovation Network liaison team at ctsi@buffalo.edu — indicate “Trial Innovation Network” in the subject line — or fill out a service request and check the “Recruitment Tactics Assistance” box.