New approaches boost access to innovative clinical research

Since 2015, when the National Institutes of Health awarded UB the Clinical and Translational Science Award (CTSA), clinical trial research has significantly expanded. That expansion has brought with it a stronger emphasis on using new approaches, both high-tech and low-tech, to bring cutting-edge health care to more Western New Yorkers.

They all have one ultimate goal: to make it easier both for researchers to identify patients who may be good candidates for trials and for patients to find relevant trials in which to participate.

“The chief difficulty of conducting clinical trials is the time and the cost it takes to identify and recruit participants,” explains Timothy F. Murphy, senior associate dean for clinical and translational research, director of the Clinical and Translational Science Institute (CTSI) and SUNY Distinguished Professor in the Jacobs School of Medicine and Biomedical Sciences. “Some trials never even get started and others never finish, all because of a lack of participants. About 75 percent of all clinical trials are never completed because they fail to meet their required recruitment goals.”

Last spring, UB was invited to join the CTSA Accrual to Clinical Trials (ACT). “Most of the trials we can access through ACT are NIH-funded, are highly innovative and carry significant potential impact to truly improve health outcomes,” Murphy says.

ACT is designed to mitigate the challenges of initiating and running a clinical trial by using a common institutional review board model, sharing de-identified electronic health record (EHR) data, (stripped of 18 different identifiers) and using other methods to accelerate the startup of clinical trials.

For example, ACT uses Informatics for Integrating Biology & the Bedside (i2b2), an open source software system that permits searching of de-identified clinical patient data. The software enables different sites participating in ACT to share de-identified EHR data in order to identify which ones have the appropriate patients for a specific trial.

UB uses i2b2 to do the same thing: to find out how feasible a specific type of clinical trial might be within the Western New York region, based on the EHR of UBMD Physicians’ Group, the medical group associated with the Jacobs School.

“The ACT model represents the future of how clinical trials will be run,” says Murphy, “reducing what are sometimes tremendous delays in startup due to regulatory and contracting issues.”

UB is also bringing more industry clinical trials to the region. In 2017, UB teamed up with TriNetX, a network comprised of health care organizations representing more than 84 million patients globally, biopharmaceutical companies, and contract research organizations.

Peter Winkelstein, executive director of UB’s Institute for Healthcare Informatics, professor of pediatrics in the Jacobs School and chief medical informatics officer for UBMD, described TriNetX as a kind of “matchmaker” that works to pair academic health centers with companies looking for patient populations to test new treatments.

“It’s a different twist on clinical research,” he says. Often, he notes, research is investigator-initiated, but here, it’s industry that’s funding the research, as long as they can identify the appropriate investigator and the right patient population.

“We see this as an opportunity to increase clinical trial activity at UB,” says Lisa Zander, manager at the UB Institute for Healthcare Informatics. “The more clinical trials we can be part of, the more it helps promote state-of-the-art health care, improves health outcomes in our community and advances the university’s mission.”

Winkelstein explains: “The point of all these systems is to make it as easy as possible for a potential researcher or funder to answer the question, can you do a trial on this drug or treatment here? Are there enough potential patients here?”

UB also works with Circuit Clinical, a clinical research site network based in Buffalo and dedicated to rapid, high-quality patient recruitment and enrollment. The company works to bring new patients and physicians into clinical trials by simplifying enrollment and enhancing outreach to doctors and patients.

Individuals who want to participate have more options as well. They can sign up with ResearchMatch.org, a national, online service that UB participates in that matches clinical trials with interested individuals. They can also access the Buffalo Research Registry, UB’s growing database of potential patient volunteers in Western New York who want to learn about local research projects that match their interests and needs.

“The Buffalo Research Registry is strictly local and is aimed at reducing barriers to getting involved in clinical trials,” says Danielle Abramo-Balling, community recruitment liaison with the CTSI. “We designed it to be accessible to everyone, even those who don’t have reliable access to the internet.” People can sign up for it through regular mail or email. More information is available on its website or by calling the community engagement line at 716-829-2502.

“We really want people of all backgrounds and abilities to be able to get involved, and we are happy to personalize approaches as best we can to make sure our local communities can be engaged,” she says.

And Western New Yorkers are interested, according to a community survey conducted by the community engagement team in 2016. The survey, completed by 154 community members at local events, found that 65 percent of respondents wanted to hear more about research happening in Western New York from their physician, but just 13 percent said their doctor had actually discussed research with them.

“This was clearly an opportunity for us,” says Sanjay Sethi, medical director of UB’s Clinical Research Office and chief of pulmonary, critical care and sleep medicine at the Jacobs School and UBMD Internal Medicine.

Last year, when UBMD practice plans started moving to the fourth floor of the Conventus Building downtown, the decision was made to use the new central location to engage and offer clinical research opportunities to patients. A research education table was installed in the fourth floor lobby, where patients can find information about trials approved by the Institutional Review Board that are currently recruiting participants.

The table is staffed three days a week by paid patient ambassadors from the Patient Voices Network, trained in peer-to-peer support and in answering patients’ questions. The goal is to create awareness about clinical trials and to get people talking and engaged in conversations about research that will have an impact on them.

“Research shows that patients who participate in clinical studies are more satisfied with their health care and typically enjoy better health outcomes,” Sethi says.