South Carolina Clinical & Translational Research (SCTR) Full-Throttle Ahead Clinical Research in a COVID-19 World

South Carolina Clinical & Translational Research (SCTR) Full-Throttle Ahead Clinical Research in a COVID-19 World

The South Carolina Clinical & Translational Research (SCTR), one of the more than 60 Clinical and Translational Research Award (CTSA) hubs across America, they have been on a mission for over a decade to streamline clinical trials so that patients can get access to treatments faster. The global pandemic—with the spreading of COVID-19has been a reminder as to the importance of research acceleration. What if there was a treatment to SARS-CoV-2, for example? Now new challenges are introduced in the age of lockdowns and social distancing. How can research move forward? SCTR is harnessing everything it knows to not only keep research moving in the Palmetto State.

Research Acceleration in the Age of COVID-19

SCTR’s team has accumulated a lot of experience in how to streamline research and they are doing just that as recently reported in Mirage News. First to keep information organized, they introduced a website consolidating all of their COVID-19 clinical research information. For example, they recently launched a clinical trial of an at-home COVID-19 antibody test for health care workers in only 14 days. Additionally, based on a collaboration with the Pulmonary and Critical Care research unit, SCTR opened the MUSC site of a trial testing the efficacy of hydroxychloroquine. Not resting, the team pounded on national convalescent plasma studies commencing a trail involving expanded access for critically ill patients to plasma from recovered COVID-19 patients.

Who is SCTR? Their background?

The South Carolina Clinical & Translational Research (SCTR)was established by the Medical University of South Carolina (MUSC) in 2006 in response to the NIH Clinical and Translational Science Award (CTSA) Program. The CTSA program develops innovative ways to turn observations from the laboratory, clinic, and community into interventions that improve individual and public health. SCTR has been continuously NIH-funded since 2009.

What is SCTR’s reach in the State of South Carolina?

Strong. SCTR partners with collaborators, including Clemson University, Health Silences South Carolina, South Carolina State University, the University of South Carolina, and the South Carolina Research Authority. SCTR’s network of collaborating institutions spans the United States.

What are SCTR research program focus areas?

SCTR’s research spans the stages of translational research through discovery to implementation. They are organized into programmatic areas such as Biomedical InformaticsPilot Translational & Clinical Studies (PTC)Multisite Trial Support to Research Opportunities and Collaborations (ROC) program to just name just a few. ROC for example, facilitates the start up of both industry-sponsored and investigator-initiated trials at MUSC,

What does SCTR’s Research Coordination and Management Program do?

This program provides for-fee research coordination to over 90 research projects across campus. This project is also driving the very important effort to adapting ongoing non-COVID-19 clinical trials to a virtual format. This group now must consider the ramifications for studies that have been impacted by the pandemic. Their program director, Clare Tyson, reported that the group must “ensure a continuity of care for those participating in clinical trials and receiving investigational medications, while at the same time exercising COVID-19 risk mitigation strategies.”

Staff Point of View:  Full Throttle to Improve Research & Help Patients

Signe Denmark, associate director of the Research Opportunities and Collaborations (ROC) program in the Office of Clinical Research emphasizes their state of mind today: “Talk about just hitting the reset button and reinvigorating your passion for why you do what every day.” Ms. Denmark continued, “It brings to the forefront this sense of urgency and purpose and makes us grateful that we’re working so collaboratively with an incredible team of people to figure out new ways to do things.”

While Amanda Cameron, SCTR project manager for the Trial Innovation Network, points out, “We are creating and adopting processes overnight that could have taken us years to develop.” Ms. Cameron continued, “This is moving research to a whole new level that that’s going to help the future of how research is one.” A note on the Trial Innovation Network—a CTSA-sponsored initiative to make CTSA hubs across America aware of NIH-funded investigator-initiated trials.

How as SCTR dealt with social distancing? What does their transition plan for studies look like?

Clare Tyson’s team were hit first with queries about how to transition in this pandemic world.  She noted that they need to rapidly develop a roadmap to transition trials. As a first step, Tyson and team reached out to study sponsors to assess what could be modified in the study protocols to encourage virtual and remote coordination initiatives. Of course, patient safety nor data integrity could be compromised. The team leveraged a shared set of questions for sponsors to streamline the transition process.

How did the team deal with the challenges of scaling up remote clinical trials in a COVID-19 world?

As it turns out one can’t just flip a switch and go from more conventional studies to primarily remote studies. Hence, new challenges surfaces involving topics such as infrastructure. How would the investigational drug get delivered to patients? What technologies could be deployed to support virtual visits? What kinds of lab testing systems could support the new reality?

Well those with a vision, strategy and organizational buy in can make amazing things happen. Hence the SCTR teams got to work assembling an institutional subcommittee made up of research stakeholders’ campus-wide—inclusive of the Institutional Review Board, SCTR’s SUCCESS center, the Office of Clinical Research, Investigational Drug Services, SCTR’s Nexus Research Lab, MUHA laboratories, the Epic research team, Hollings Cancer Center Clinical Trials Office and other research teams.  Moreover the team leveraged existing technical innovations such as electronic consent/e-Consent and MUSC telehealth expertise.

MUSC SCTR in fact had much of the systems and processes already ready?

As it turns out, SCTR already has many of the systems, technologies and infrastructures in place for the transition to a COVID-19-based virtual world. They just were not using them. The committee did have to develop new guidance parameters as well as look to reconfiguring some workflows for more seamless integration into the research environment. But they are well on their way. As reported in Mirage, study teams can ship investigational medications to study participants not to mention conduct remote study virtual visits via telehealth platform.