What good are medical innovations if they never reach patients? UB researchers have $3 million grant to make sure they do

BUFFALO, N.Y. — New drugs and diagnostic tests go through years of clinical trials before being approved. But while regulatory approval is an enormous hurdle, getting through that process doesn’t automatically ensure that patients have access to these medical innovations.

Now, a new field called implementation science is evolving to facilitate the transition from clinical trials to clinical practice. The Clinical and Translational Science Institute (CTSI) in the Jacobs School of Medicine and Biomedical Sciences at the University at Buffalo recently announced the funding of two faculty scholars who will focus on this new science so more patients benefit from innovations. They are:

·         Shirley S. Chang, MD, assistant professor, UB Department of Medicine, Division of Nephrology, a transplant nephrologist at Erie County Medical Center and a physician with UBMD Internal Medicine. She will study implementation strategies for appropriate use of medications that inhibit the renin-angiotensin system, which regulates blood pressure and fluid balance, in patients with congestive heart failure.

Primary mentor: Katia Noyes, PhD, director, Division of Health Services Policy and Practice, and of epidemiology and environmental health, UB School of Public Health and Health Professions.

·         Brian Clemency, DO, associate professor, UB Department of Emergency Medicine, program director of UB’s fellowship in pre-hospital care, Emergency Medical Services and a physician with UBMD Emergency Medicine. He will study ways to bridge the gap between current knowledge of cardiopulmonary resuscitation quality and its optimal implementation in pre-hospital settings.

Primary mentor: David Hostler, PhD, chair, Department of Exercise and Nutrition Sciences, UB School of Public Health and Health Professions.

The funding comes from a $3 million award to UB’s CTSI in 2017, one of just 10 grants in the U.S. awarded for this purpose by the National Heart, Lung and Blood Institute of the National Institutes of Health. Called a K12 award, it is an institutional career development award designed to promote recruitment and retention of the best and the brightest to UB.

“With these translational science grants, NIH wants to bring more relevance to research,” said Ranjit Singh, MD, associate professor and vice chair for research in the Department of Family Medicine in the Jacobs School.

Singh, who also directs the Jacobs School’s Primary Care Research Institute, is co-director on the grant with John Canty Jr., MD, SUNY Distinguished Professor, chief of the Division of Cardiovascular Medicine, and Albert and Elizabeth Rekate Professor of Medicine.

Katia Noyes, PhD, director of the Division of Health Services Policy and Practice, and professor of epidemiology and environmental health in the School of Public Health and Health Professions, is director of curriculum.

‘Late-stage’ translational science

While translational science is the effort to speed the delivery of medical advances to patients, implementation science is sometimes described as “late-stage” translational science in that it involves ensuring that the community has the broadest access possible to those advances.

In its Request for Applications, the NIH stated “this program is not focused on traditional explanatory science that tests interventions under ideal conditions, but rather on how to translate confirmed evidence into practice by patients, providers or health systems under usual conditions.”

In other words, said Singh, “To translate innovation to the real world, you need to go to real practices and real patients.

“Most clinical trials are performed in controlled settings,” he explained. “To be in a trial, patients need to meet strict criteria and the treatment needs to be delivered with a very high degree of fidelity. This rigor is necessary to prove that the intervention, such as a medication, is truly efficacious for the intended patients,” he continued. “But translating an innovation to the real world requires working with busy clinical teams and with diverse patients, who don’t necessarily fit the mold.”

He said patients may have multiple medical conditions and treatments that they are juggling, and face financial and social challenges and other stressors. “Similarly, providers have limited time with patients, and are under pressure to see more patients and meet new quality metrics that may not align with the patient’s goals,” he added.

John Taylor, executive director of development for UB’s Primary Care Research Institute, put it this way: “Much of what is recommended based on traditional science is not doable in the real world. This grant is about how to get that science into the real world, what’s doable by the provider or patient.”

‘Dirty science’

Singh said implementation science includes “pragmatic clinical trials,” which are sometimes perceived as “dirty science” because they relax many of the traditional requirements for methodological rigor needed for the more familiar randomized controlled trials.

“Pragmatic clinical trials and other implementation science studies aim to demonstrate effectiveness with diverse patients in diverse settings, and to understand what strategies are needed to incorporate the treatment into routine practice,” he said.

This requires a different set of approaches. Some aspects of methodological rigor, such as those based on narrow patient selection and very precise procedures, are relaxed out of necessity, while others are retained.

“The key is to make careful, deliberate choices in the research design to ensure that the results are relevant and inform future practice,” said Singh.

The scientific rigor, he continued, is improved by the use of established theories and models of adoption and implementation that draw from multiple scientific disciplines.

“This is a challenging field because it covers the whole spectrum of how new medical approaches can be adopted, from the policy level down to the individual medical practice or patient,” said Singh.

Taylor noted: “Implementation science is about what makes something implementable and what the barriers are. The biggest challenge is engagement.”

The grant funds two positions this year and three to five over the next four years, supporting mentored research and career development for faculty scholars, either currently at UB or new recruits, in implementation research. Their charge is to address the complex process of bridging research and practice in real-world settings.

The program is especially interested in novel approaches to reducing health disparities in clinical populations and increasing diversity in the clinical and translational workforce.