Clinical trial funding at UB increases significantly as thousands enroll

A comprehensive, university-wide effort to boost clinical research at UB is paying off. Since 2015, the university has increased by more than 30 percent the funding it receives to conduct clinical trials supported by both the federal government and private industry.

More importantly, the number of Western New Yorkers now participating in UB clinical research exceeds 2,000, and more people in the region who have been affected by health disparities are now participating.

“Clinical trials are how patients get access to the best science there is,” explains Peter Winkelstein, executive director of UB’s Institute for Healthcare Informatics, professor of pediatrics in the Jacobs School of Medicine and Biomedical Sciences at UB, and chief medical informatics officer for UBMD Physicians’ Group.

“Treatments available through clinical trials are better than anything else that’s already out there,” he says. “You can’t get these treatments unless you are in a clinical trial. So it’s a tremendous opportunity to bring the best therapies to Western New York. It’s good for the patients, good for the university and good for the companies we partner with to improve health care. It’s a win-win-win.”

According to UB’s Office of the Vice President for Research and Economic Development, in the past two years, the number of patients enrolled in UB clinical trials has increased by 65 percent, from 1,334 in 2015 to 2,210 in 2017. And in fiscal year 2017, UB’s clinical research expenditures were $14.4 million, up from $11.4 million in 2016 and $10.9 million in 2015. This information pertains only to clinical trials being run by UB, not those being run by its partners.

Current clinical trials at UB range from testing new treatments for diabetes, Crohn’s disease, psoriasis, hepatitis C and dementia to how to prevent obesity in preschoolers and helping pregnant women to stop smoking and much more. Information on how to participate is available online.

“This significant increase in the funding UB’s academic health center receives from clinical trials and research translates to a real advance in boosting Western New Yorkers’ access to the newest, best diagnostic tests and treatments available anywhere,” says Michael E. Cain, vice president for health sciences and dean of the Jacobs School.

What triggered the boost? University officials say it was the concerted and strategic effort undertaken by UB when it applied for, but didn’t receive, a planning grant for a prestigious Clinical and Translational Science Award (CTSA) from the National Institutes of Health in 2006. Those awards are focused on speeding the delivery of new drugs, diagnostics and medical devices to patients.

“The proposal got important, good reviews saying that UB had many pillars and islands of excellence,” Cain recalls, “but it wasn’t funded because we hadn’t yet demonstrated that we were working as a truly collaborative group.”

Significant change was already underway:

• President Satish K. Tripathi, serving as university provost in 2007, worked with the deans and faculty to develop the institutional infrastructure so that multidisciplinary research collaborations could flourish.
• UB joined with Kaleida Health to design and build UB’s Clinical and Translational Research Center on the floors above Kaleida Health’s Gates Vascular Institute.
• The expanded, new home of the Jacobs School, which would help in recruiting new faculty, was in the planning stages downtown.
• The Conventus medical office building, a new, downtown home for UBMD, the medical group associated with the Jacobs School, was in the planning stages.
• A group of more than 100 faculty and researchers was convened to work on developing a strategic approach to clinical and translational research.
• Timothy F. Murphy, SUNY Distinguished Professor, was named senior associate dean for clinical and translational research.
• New infrastructure was developed to streamline and more efficiently support clinical research, especially the Clinical Research Office, which launched in 2013, creating a single entity to handle all aspects of clinical research at UB.

Ultimately, UB was successful with its 2015 application for the CTSA. UB then established its Clinical and Translational Science Institute (CTSI) to better enable the university and its partners in the Buffalo academic health center to conduct large, high-impact, multi-center clinical trials.

Integral to the improved climate for clinical research are UB’s stronger connections with partners on the Buffalo Niagara Medical Campus, such as Kaleida Health, the region’s largest health care system. Kaleida Health is beginning to share health information with UB, creating a regional database of more than 1 million de-identified patients when combined with records from UBMD.

UB has also strengthened collaborations with Erie County Medical Center, the Western New York Veterans Affairs Health Care System, Roswell Park Comprehensive Cancer Center, and beyond. At the same time, the UB Department of Emergency Medicine, whose physicians staff the region’s highest-volume emergency departments through UBMD Emergency Medicine, has enhanced its role in recruitment. Where appropriate, emergency medicine research associates educate patients who come to the Emergency Department about relevant clinical trials, facilitating enrollment when there is interest.

“This substantial increase in research activity at UB is a result of all the changes this institution has made in a variety of areas to foster better health care in our community,” says Murphy, who also serves as director of the CTSI. “Those efforts signaled UB’s strong institutional commitment to growing clinical research with a multimillion-dollar investment that allows us to fully support and perform world-class clinical research. Now they are paying off.”

Adds Venu Govindaraju, UB’s vice president for research and economic development: “From the establishment of a centralized office that administers all clinical research at UB to the investment of resources to much more closely engage with the community, we have embarked on a new era in research and health care in Western New York.”

Sanjay Sethi, professor and chief of pulmonary, critical care and sleep medicine, director of CRO and a physician with UBMD Internal Medicine, agrees. “The Clinical Research Office and the CTSI provide the infrastructure that top-notch clinical trials require,” he notes, “as well as the resources necessary to conduct meaningful community engagement, support our researchers with CTSA pilot grants and provide the training opportunities that allow UB investigators to thrive.”

And while increased clinical trial activity is key to the mission of academic health centers, the most important advantage is the fact that more Western New Yorkers are now personally benefiting.

UB continues to work to make its clinical trials more inclusive and representative of the region’s diverse population. The number of participants in UB clinical trials who experience health disparities has increased from 27 percent in 2015 to 41 percent in 2017. Recruitment is focused on populations in the city and close to the Jacobs School’s new downtown location, home to largely underrepresented groups.

“Our community — the city of Buffalo in particular — is 50 percent underrepresented minority and 30 percent of residents live below the poverty level,” Murphy says. “These people have traditionally been excluded from the benefits of participating in clinical research. One of our major focuses is to engage these communities so that they, too, can benefit from access to the best treatments. We want people participating in clinical trials to be representative of our community.”

Murphy credits the CTSA with UB’s ability to significantly increase outreach efforts that can be sustained over the long term. A recruitment team now works with clinical researchers to recruit community members into clinical trials, meeting with local groups to understand what kinds of health care issues and questions they want to see investigated.

A host of initiatives, many prompted by the move of the Jacobs School downtown, are breaking barriers between the health care system and the community. UB faculty have joined the African American Health Disparities Task Force, a community coalition working toward health equity in Buffalo. And faculty, students and community members are beginning to address disparities through new courses and partnerships with local churches, coordinated by the Jacobs School’s Center for Medical Humanities.

The CTSI’s Community Engagement Team, one of UB’s longest-standing efforts to improve access to care for people impacted by health disparities, originated with a Department of Family Medicine program led by Laurene Tumiel-Berhalter, director of community translational research. She works closely with the Patient Voices Network, a group of informed and empowered patients in the community who advocate for improved health care in Western New York. They serve as patient ambassadors to find out about health care needs and concerns in the community while encouraging participation in clinical research.

“The community members who sit on our steering committee help UB researchers learn what major health issues are affecting them so that our faculty can design studies that produce the most meaningful results,” Tumiel-Berhalter says. “We could not ask for a more engaged, better-informed group of community advisers.”