Bringing the benefits of clinical research within reach for all South Carolina communities

The South Carolina Clinical & Translational Research Institute (SCTR), a statewide initiative that provides consultative expertise, resources, training and funding to support research teams, has been awarded $26.5 million in grant funding over the next seven years from the National Center for Advancing Translational Sciences (NCATS) Clinical and Translational Science Awards (CTSA) program at the National Institutes of Health.

SCTR has been a CTSA hub since 2009, one of over 60 in the nation. Over the past 16 years, it has built a robust research infrastructure, trained MUSC’s and South Carolina’s clinical research workforce and introduced clinical trial and bioinformatics innovations adopted by CTSAs across the country.

“Receiving this award underscores the power of collaboration and innovation across South Carolina’s research community,” said MUSC Vice President for Research Timothy Stemmler, Ph.D. “By expanding access to clinical trials and accelerating the translation of scientific discoveries into real-world solutions, SCTR is ensuring that every South Carolinian can benefit from the latest advances in health care. This investment will strengthen our state’s research infrastructure and serve as a model for advancing health nationwide. The dedication of the SCTR team exemplifies the transformative role academic medicine plays in shaping a healthier future for all.”

“By expanding access to clinical trials and accelerating the translation of scientific discoveries into real-world solutions, SCTR is ensuring that every South Carolinian can benefit from the latest advances in health care."

-- MUSC Vice President for Research Dr. Timothy Stemmler

The NCATS funding will be used to overcome barriers that slow the translation of scientific discoveries to clinical practice; improve access to clinical trials and evidence-based therapies for South Carolinians, especially those residing in rural areas; and build a robust, translational research workforce statewide.

To achieve these goals, SCTR will collaborate closely with the University of South Carolina (USC), well-known for its expertise in public health and community-engaged research, and South Carolina State University (SCSU), recognized for strong accomplishments in training undergraduates in science, technology, engineering and math fields.

“This award is a testament to what has been accomplished by this very talented team. We are building on our previous successes and expanding our reach in translational science,” said Patrick A. Flume, M.D., the Powers-Huggins Endowed Chair for Cystic Fibrosis and one of the SCTR co-directors.

Kathleen T. Brady, M.D., Ph.D., founder and co-director of SCTR, echoed Flume’s sentiments. “SCTR has been the backbone of research support, acceleration and innovation for the past 15 years,” said the Distinguished University Professor. “This seven-year award will allow SCTR to continue to grow, develop and innovate in research for MUSC.”

“The challenges in clinical research that we face are not unique to South Carolina. As we learn more about how to clear hurdles, getting research opportunities to everyone in the state, we will share this new knowledge with the rest of the country.”

-- SCTR co-director Dr. Patrick Flume

For this award, SCTR will focus more of its resources on addressing bottlenecks that lead to failed clinical trials and delay new evidence-based therapies from reaching the patients who need them. This “translational science” approach focuses on overcoming obstacles commonly faced by studies so that a solution will have more widespread impact nationally. The new SCTR Research Innovations Promoting Translation (SCRIPT) program is intended to fund projects that show strong promise for addressing these translational bottlenecks. MUSC’s pilot project program, which will offer competitive funding opportunities for translational science studies, will serve as one of the seedbeds for new ideas for SCRIPT projects. SCTR will focus especially on research roadblocks common in rural Southern states, such as limited access to clinical trials and slow adoption of evidence-based innovations by community providers.

“SCTR has been the backbone of research support, acceleration and innovation for the past 15 years. This seven-year award will allow SCTR to continue to grow, develop and innovate in research for MUSC.”

-- SCTR founder and co-director Dr. Kathleen Brady

In largely rural states like South Carolina, medical expertise and clinical research opportunities are concentrated in cities, making access difficult for rural residents. Finding ways to address these bottlenecks could improve rural health and clinical trial participation, not only in South Carolina but across the nation.

SCTR will grow the clinical research footprint in South Carolina by supporting research throughout MUSC Health’s Regional Health Network (RHN). With funding from The Duke Endowment, SCTR has already established research centers at two RHN hospitals, MUSC Health Florence and Lancaster medical centers, and is working with research teams to grow clinical trials in the MUSC Health-Midlands Division and at MUSC Health-Orangeburg. These research centers will enable community members to join clinical trials closer to home.

SCTR is not stopping at bringing research expertise closer to rural residents. It is also rethinking clinical trials, using innovative approaches that make it easier for patients to participate remotely. These decentralized trials use telehealth to communicate with patients and phone apps to collect patient data while capitalizing on digital innovations such as e-consent to streamline remote recruitment.

Once therapies or other interventions shown to be effective in clinical trials have been approved for wider use, it can be difficult for busy community medical practices to adopt them. The first step is to make these practices aware of the new therapy, followed by the implementation of the innovations in the practices without placing too much burden on the established workflow and staff. It can be challenging to adapt these evidence-based innovations into real-world community settings, as clinical trials carefully select patients and follow stringent protocols for care and are often run in academic medical centers.

Some tailoring of the innovation will be needed for different settings without losing its efficacy. Dissemination and implementation science strives to get this balancing act right. In this award, these strategies will be integrated into all SCTR initiatives. SCTR is also offering Dissemination and Implementation Science Consultative Studios, modeled after the studio program at Vanderbilt University, to help researchers and research trainees to gain expertise in this emerging field, which plays a critical role in ensuring that patients benefit from advances in clinical research.

For evidence-based preventive and therapeutic approaches to begin to make a real difference in a community’s health, members of that community need to be receptive to them. Community members are more receptive to these approaches if they learn of them from someone they trust and if any fears, misgivings or difficulties accessing care are discussed frankly. Community-engaged participatory researchers, such as Gayenell Magwood, Ph.D., of USC, listen to the ideas and concerns of community members and use them to refine research priorities, shape how research studies are carried out and guide the rollout of evidence-based innovations.

SCTR has an impressive track record of building bridges between researchers and community members, having supported 44 community-academic partnerships through its Community Engaged Scholars program since 2009. It also offers evidence academies, most recently in rural health and pediatric oral health care, which bring together researchers, health professionals, policy makers and community members so they can discuss and agree on evidence-informed strategies for addressing health challenges. The collaboration with USC will build on these successes and extend the reach of SCTR community-based initiatives.

If a more robust translational research workforce is to be built and sustained, students must be made aware of career pathways in clinical and translational science earlier in their educational journeys. For this award, SCTR will collaborate with SCSU, which has established an Honors Program in Applied Oncology Sciences. Students in the program have the opportunity to work in MUSC laboratories over the summer to learn more about biomedical research. To ensure that students are also made aware of clinical research opportunities, SCTR will invite two interns to embed with clinical research coordinators to gain invaluable experience in how clinical trials are designed, carried out and managed.

Through these initiatives, SCTR aims to remove roadblocks that keep clinical research breakthroughs from reaching patients and providers, particularly in rural areas. They will share their successes with the broader CTSA consortium so that hubs in other rural states can implement these strategies to improve public health and ensure that research advances and evidence-based therapies are available to all.

“The challenges in clinical research that we face are not unique to South Carolina,” said Flume. “As we learn more about how to clear hurdles, getting research opportunities to everyone in the state, we will share this new knowledge with the rest of the country.”