CTSA News

The University at Buffalo Clinical and Translational Science Institute (CTSI) has a long history of supporting investigators in their efforts to obtain external funding via CTSI Biostatistics, Epidemiology, and Research Design (BERD) Core consultations, collaborations and educational resources for study design and statistical analysis.

In recent years, UB has expanded this capacity and support with the establishment of UB’s Office of Clinical Trial Development and Implementation (OCTDI). The OCTDI serves as a centralized hub for interdisciplinary clinical trial research collaboration for UB investigators and regional and industry partners. Founded in 2024, it was funded by and exists within the Office of the Vice President for Health Sciences, with a physical location on UB South Campus.

Serving as OCTDI Director is CTSI BERD Core Director Gregory Wilding, PhD, Professor, Department of Biostatistics, School of Public Health and Health Professions. He explains the mission of the OCTDI is to improve the planning and conduct of clinical trials by providing high quality statistical and data management support and workforce training.

These are unique offerings for local investigators, Wilding says. “There are larger clinical trial support operations at institutions such as Duke, Stanford, and Johns Hopkins. We are operating on a smaller scale, but the underlying concept is similar — bringing high level expertise together in a centralized resource focused specifically on supporting clinical trials. The OCTDI is the only unit within the SUNY system organized around this type of support.”

CTSI Director Sanjay Sethi, MD, SUNY Distinguished Professor, Senior Associate Dean for Clinical and Translational Research, Jacobs School of Medicine and Biomedical Sciences, says the university recognized the need for a central mechanism to provide large-scale, integrated, comprehensive coordination of statistical and data management activities to enhance existing support mechanisms.

“From a CTSI perspective, there is a great deal of synergy between the OCTDI and our BERD Core, which offers biostatistical, epidemiological and research design support to investigators,” Sethi says. “Both the OCTDI and BERD Core are here to provide support before and during the grant proposal process.”

A pressing need

It was during brainstorming sessions involving both School of Public Health and Health Professions, Jacobs School, and CTSI affiliated faculty, Wilding explains, that the need for a centralized clinical trial resource was first discussed. The office was conceived to address many of the challenges that arise throughout the clinical trial lifecycle, and to serve as a centralized mechanism to provide large-scale, integrated, comprehensive coordination of statistical and data management activities for common clinical trial-oriented research projects or causes. Wilding says many of these challenges became apparent in the BERD core’s work with investigators in the planning of clinical trials.

“Coordination becomes especially important as investigators pursue more innovative approaches to clinical trials, including adaptive designs, which require statistical and data management considerations to be tightly integrated throughout the planning and conduct of the study,” Wilding says. “Having the infrastructure and expertise to support these modern designs can also make investigators more competitive for grant funding.”

Jill Szczesek, PhD, Associate Vice President, Research Administration and Finance, OVPHS, notes that the OCTDI fills a critical gap in the infrastructure needed to support increasingly complex clinical research.

“Dr. Wilding recognized that as the University at Buffalo expands its clinical research portfolio to include larger, multi-site clinical trials, investigators need specialized operational and development support to successfully compete for and conduct these studies,” she explains. “The OCTDI provides that support in a coordinated and strategic way. This vision aligns closely with the OVPHS commitment to creating an environment where investigators have the resources, expertise, and institutional support necessary to thrive and bring innovative research opportunities to our patients and communities.”

University-wide impact

In its first few years of existence, the OCTDI has already had an impact on the research ecosystem at the University at Buffalo. Wilding says the developed trial infrastructure has already been widely leveraged by UB investigators in the creation of competitive clinical trials-oriented grant applications.

“The clearest feedback has been the requests for collaboration,” Wilding says. “Investigators have been very receptive to having coordinated support available, and interest has continued to grow since the office was established.”

Szczesek agrees that the impact of the office has been profound, noting, like Wilding, that interest in services has been strong.

“Since its founding in late 2024, the OCTDI has quickly become a critical resource,” she says. “The team is supporting investigators and study teams across the institution in both proposals and awards, and we are preparing to hire a second data manager to meet growing demands. Our first data manager, Austin Glick, has been so successful that his position is now fully supported through external funding. Further evidence of the initiative of our faculty and their desire to be impactful in the trial space for our community.”

“Going forward,” Wilding says, “I hope to continue expanding our capacity, particularly to support larger and more innovative trials while maintaining the quality and consistency of the support we provide.”

Due to a high volume of requests, those interested in utilizing OCTDI services are encouraged to contact Wilding at gwilding@buffalo.edu at least two months in advance. He anticipates office-assisted projects to continue to increase in the months and years to come.

“The interest we have seen reinforces that this is a resource that UB investigators need,” Wilding says. “Our goal is to continue building the infrastructure and expertise needed to help investigators develop competitive proposals and conduct increasingly complex and innovative clinical trials here at UB.”