Published August 19, 2020
When the University at Buffalo's $15 million Clinical and Translational Science Award (CTSA) from the National Institutes of Health (NIH) was announced in 2015, it was heralded as a game-changer in the pursuit for improved health and reduced health disparities in Western New York. Five years later, it is clear that the impact of UB’s Clinical and Translational Science Institute (CTSI) on Buffalo has been vast. And the CTSI story is just beginning.
“In just five years, UB’s Clinical and Translational Science Institute has truly enhanced the health and well-being of citizens across our region and well beyond,” says UB President Satish K. Tripathi. “It has allowed UB to leverage our substantial research strengths and our longstanding collaborations to advance health equity and realize a cornerstone of our university’s mission — to harness our education, research and scholarship for the greater good. Considering all that UB’s CTSI has accomplished in such a short period of time, I greatly look forward to the innovative solutions it develops — and its meaningful contributions to health outcomes — in the years ahead.”
Timothy F. Murphy, MD, SUNY Distinguished Professor and senior associate dean for clinical and translational research, has been CTSI Director from the very start, providing leadership for the original grant application, as well as the follow-through in the last five years. These efforts culminated in the renewal of a five-year, $21.7 million National Center for Advancing Translational Sciences NIH grant in early 2020 to continue the CTSI’s growth in the healthcare and research sectors.
“In just five years, the CTSI has truly enhanced the health and well-being of citizens across our region and well beyond. It has allowed UB to leverage our substantial research strengths and our longstanding collaborations to advance health equity and realize a cornerstone of our university’s mission — to harness our education, research and scholarship for the greater good.”
-UB President Satish K. Tripathi
“The CTSI has had a broad and transformational impact on all phases of clinical research,” Murphy says, adding that the support of UB leadership has been of particular importance to the CTSI’s growth. Murphy says leadership is and has always been “committed to raising the level of research in Buffalo and at UB.”
Michael E. Cain, MD, vice president for health sciences and dean, Jacobs School of Medicine and Biomedical Sciences, believes the CTSI has generated extraordinary changes in local healthcare, and the area’s way of life.
“The CTSI has transformed clinical and translational research in Western New York over the last five years through broad-based initiatives,” Cain says, “including a strong focus on partnering with the community to realize its mission to support innovative clinical and translational research to improve health and reduce health disparities in our community and the nation.”
“The CTSI has catapulted UB’s clinical research enterprise,” says Venu Govindaraju, PhD, UB’s vice president for research and economic development. “I am honored to play a small part in support of Dr. Murphy’s efforts as a member of the CTSI Board.”
Govindaraju specifically highlights the efforts in fighting health inequities locally: “The CTSI has done incredible things for both UB and for our community. One of the most important has been the creation of the UB Community Health Equity Research Institute, which combines the expertise of researchers and students from throughout UB, to work with community partners to address health disparities on the city’s East Side.”
Filling in the gaps
Looking back at the early days of UB’s CTSI development, Murphy acknowledges the importance of the national CTSA consortium. “We needed to implement the things that other leading institutions were doing and finding valuable,” he explains. “Interacting directly showed us where our gaps were, and then also where we were ahead.”
One such example of adopting what worked well for CTSA peers was the implementation of a clinical trials management system (CTMS) to manage clinical trials, to keep track of funding, and to automatically report metrics.
Murphy attributes the university’s centralization of many research processes as having increased the quantity and quality of research and provided “uniformity — in the way processes are done,” adding, “The Office of the Vice President for Research and Economic Development, the Office of the Vice President for Health Sciences, and the CTSI talk all the time and implement things together.”
Improving processes has also increased recruitment, contributed to community engagement, and influenced how researchers recruit participants for clinical trials.
“One of our emphases is to engage people who have not traditionally been engaged in the clinical research enterprise — underrepresented minorities; people who experience health disparities; and people who have barriers to participating in clinical research, whether it is childcare, medication, fear, or mistrust of research,” Murphy says.
The CTSI team is helping to reduce the barriers to participation in research, he explains, by working closely not only with researchers but with members of the community, as well.
“The CTSI has transformed clinical and translational research in Western New York over the last five years through broad-based initiatives, including a strong focus on partnering with the community to realize its mission to support innovative clinical and translational research to improve health and reduce health disparities in our community and the nation.”
-Michael E. Cain, MD
“It is not like we have a solution to every problem,” Murphy states, “but more and more people are changing how they think about clinical research.”
A total of 70 faculty members from eight UB schools and Roswell Park have provided expert leadership with effort on the CTSA grant since 2015. Currently, the CTSI team includes 18 full-time and eight part-time staffers.
All of the CTSI’s achievements, Murphy says, are a result of the contributions of faculty experts and committed CTSI staff: “None of this would have happened without the faculty and staff, not to mention the members of our Board and our Steering Committee. I am honored to have the opportunity to work with these dedicated individuals, and to see their impact on clinical and translational research at UB, with UB’s clinical partners and in the community.”
Moving the needle
At the start of the grant, Murphy says, developing and improving research processes was essential. He also emphasized the importance of “moving the needle” and “making a difference,” acknowledging the difficulty of both the goal and the measurement.
One area in which change is particularly difficult is the reduction of health disparities, which, Murphy says, unfortunately have not changed in a generation. The goal is to improve hospitalization rates, mortality, and incidence of disease in people in our community. The work being done by the CTSI, UB leadership, and community partners will ultimately be measured by these ambitious outcomes.
“We’re doing things so we will be able to have a generational impact,” Murphy explains. “The UB Community Health Equity Research Institute arose as a result of the partnership between the African American Health Equity Task Force and the CTSI. Together, we have brought attention to the importance of investing in solving health disparities and inequities. That is a critically important outcome for our community and for the university.”
“The CTSI has done incredible things for both UB and for our community. One of the most important has been the creation of the UB Community Health Equity Research Institute, which combines the expertise of researchers and students from throughout UB, to work with community partners to address health disparities on the city’s East Side.”
-Venu Govindaraju, PhD
Murphy sees signs of change, with more researchers looking at health disparities and more projects in partnership with the community to specifically address these issues.
“Real progress will be changing the big-time metrics,” Murphy says. “Yet we still need to look at the intermediate things. Are people getting more access to healthcare and healthy foods? Are the neighborhoods and housing improving? Is unemployment going down? Are the rates of COVID-19 in the communities going down?”
Indeed, Murphy points to one telling recent statistic as an achievement that resulted from community-based efforts and university partnership: On April 7, 67% of COVID-19 deaths in the City of Buffalo were in African Americans. Seven weeks later, on May 28, that number decreased to 45%. While any loss of life is tragic, these statistics do provide evidence of the efficacy of local efforts.
“The community did the hard work, going out to check on people and setting up testing sites,” Murphy says. “That is acute mitigation. We also need to commit a robust, multidisciplinary effort toward solving the underlying problem of health disparities.”
Raising the level of clinical research
Another achievement from the last five years, and another example of finding a gap and filling it, is the CTSI’s focus on training and workforce development, specifically in clinical and translational research.
Murphy cites the establishment of the CTSI Core Competency Workshop Series as “incredibly influential in terms of the number of people who have attended, and in the wide range of trainees. We are not only moving people’s careers along, but also raising the level of clinical research.”
The CTSI’s digital badges and micro-credentials have become increasingly popular, and Murphy sees this trend continuing.
“For attendees, it helps them organize their education and training programs,” he says. “It used to be a line on a resume, but now it is actually a digital badge that is linked to a formal credential endorsed by UB.”
Murphy also notes the training that has resulted from the Mentored Career Development Awards programs: “We are training the next generation of clinician scientists, and that’s with tremendous institutional support from the Jacobs School and Roswell Park Comprehensive Cancer Center.”
UB’s Pilot Studies Program in existence since 2010, expanded with CTSA grant funding that complements institutional funding from UB and Roswell Park, is another major accomplishment. Murphy points to the broad range of studies that have been supported, as well as the dramatic return on investment. Since 2015, a total of $2.8 million have been awarded for 60 pilot studies with 69 principal investigators and 148 co-investigators from seven UB schools and Roswell Park. Pilot studies completed beginning 2010 through early 2019 have generated almost $17 million in extramural funding — a nearly seven-fold return — and important clinical and translational research.
“It has been an important mentoring tool for junior investigators to be mentored by [more experienced] investigators,” Murphy says. “Several have received their first national funding and have been promoted to tenure during the course of the program.”
Murphy says the streamlining of clinical research is a noteworthy achievement, and its impacts have been tangible. “IRB turnaround times have gone down, and contracting has sped up,” he says.
The growth of clinical trials is another noteworthy achievement for investigators and research teams from UB’s various departments and schools. Consider that during the last five years:
“I like to believe that the CTSI has had an influence over those areas — changing the culture and changing the way that many people think,” Murphy says.
All of the CTSI cores contribute to these successes, Murphy says. These include:
Working toward a streamlined, more efficient future
Murphy says the CTSI has “big goals” for the next five years. One involves the area’s electronic record infrastructure.
“We have an opportunity in Buffalo to leverage this integrated electronic health record biomedical informatics IT system through streamlined clinical trials, and to use it as a recruitment tool,” he says. “UBMD, Kaleida Health, and ECMC are all moving toward using the same electronic system. While the pandemic slowed down the implementation, this project is important because it can include the majority of the population in Buffalo.”
Other plans involve creating “better, more robust community partnerships,” continuing to grow clinical trials and community engagement, and reducing research bottlenecks.
“Guided by our overarching goal to perform research to improve the health of our community and the nation, we will embark on bold new initiatives to advance translational science, train our diverse workforce, engage our community, and share the innovations that we develop in Buffalo with the national CTSA consortium.”
-Timothy F. Murphy, MD
The recent response to the COVID-19 pandemic points to the future of clinical research at UB, as well. Along with its hospital partners and UB leadership, the CTSI jumped fully into contributing to try to solve the problem via clinical trials and clinical studies. This was possible due to the processes and training implemented since 2015.
“The first trial that we did in early April in partnership with Roswell Park, testing the antibody sarilumab, was ramped up in a week; it usually takes several months,” Murphy says. “Twenty-three critically ill patients were enrolled in that study at Kaleida, ECMC, and Millard Fillmore Suburban Hospital. This involved obtaining the consents, getting the medication under the right guidelines and strict regulatory controls, collecting all the data — all in a busy, stressful atmosphere and environment. It was a remarkable achievement by our clinical researchers.”
Reducing the usual regulatory barriers was not easy, but Murphy believes that the success in doing so is a sign of great things to come.
“It tells me we can do this — we do not need all these delays under normal circumstances,” Murphy states. “I’m hoping that will translate into an acceleration and increase in the efficiency of clinical trials in the years to come.”
The CTSI continues to support the advancement of research across the entire translational spectrum — from translating basic science discoveries into healthcare interventions to clinical trials to bringing these advances into real-world community settings, with an emphasis on engaging our diverse community, inclusive of underrepresented minorities and people with health disparities. Working closely with its community partners and UB leadership, the CTSI strives to achieve these ambitious goals through education, innovation, consultation, and support.
“When I look back on our five-year journey thus far, I am excited about building on this strong foundation," Murphy says. "Guided by our overarching goal to perform research to improve the health of our community and the nation, we will embark on bold new initiatives over the next five years to advance translational science, train our diverse workforce, engage our community, and share the innovations that we develop in Buffalo with the national CTSA consortium.”