Clinical Research in the Time of COVID-19

Patrick A. Flume, M.D.

The emergence of SARS-CoV-2, the virus behind the COVID-19 pandemic, has reminded us how important it is to speed research breakthroughs into clinical practice. 

Testing potential new tests and therapies for COVID-19 in clinical trials ensures that only those that are effective and safe make it to the clinic.

But how can the pace of those trials be sped up? How can trials be activated and patients enrolled more quickly?

The South Carolina Clinical & Translational Research (SCTR) Institute is playing a central role in addressing that issue. As one of more than 60 Clinical and Translational Science Award (CTSA) hubs nationwide, SCTR has been working for over a decade to streamline clinical trials so that patients can benefit sooner from research breakthroughs.

SCTR is drawing on that experience to fast-track COVID-19 trials. In April 2020, it was able to activate in just 14 days a trial of an at-home COVID-19 antibody test for health care workers, which has since enrolled 439 MUSC Health care providers. Once activated, many of the trials are run by the pulmonary and critical care research unit and SCTR’s research coordination and management program, which currently provides for-fee research coordination to more than 90 research projects across campus.

Thanks to these teams’ agility, more than 88 COVID-19 studies, including eight trials of therapeutics and a vaccine study (AstraZeneca), are currently active at MUSC Health. Another seven, including the trial of the at-home antibody test, have already completed enrollment and provided data to help us learn more about COVID-19. Nineteen more studies are in the process of being opened. Patients from across the MUSC Health system have benefited from these trials. For example, a program providing expanded access for critically ill patients to plasma from patients who recovered from the disease enrolled 346 patients in Charleston, Florence, Marion and Lancaster. The SCTR COVID-19 Biorepository, a “bank” of blood and saliva samples collected from COVID-19-positive patients, is open in Charleston and Florence and has so far enrolled 163 participants.

“Talk about just hitting the reset button and reinvigorating your passion for why you do what you do every day,” said Signe Denmark, associate director of the Research Opportunities and Collaborations (ROC) program in the Office of Clinical Research. “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.”

ROC, which facilitates the start-up of both industry-sponsored and investigator-initiated trials at MUSC, led SCTR’s network capacity team in launching the COVID-19 trials.

Amanda Cameron, who facilitates the feasibility and leadership evaluation process for COVID-19 trials for ROC, could not agree more. Cameron is the SCTR program manager for the Trial Innovation Network, a CTSA-sponsored initiative to make CTSA hubs across the country aware of NIH-funded investigator-initiated trials.

“We are creating and adopting processes overnight that could have taken us years to develop,” she said. “This is moving research to a whole new level that’s going to help the future of how research is done.”

Among the most exciting of the clinical research opportunities being offered to patients are treatment studies, such as that testing the experimental medication used to treat President Trump’s coronavirus infection under emergency use, and vaccine studies. Since its activation in late August, the AstraZeneca COVID-19 vaccine study has enrolled more than 600 Charlestonians. The study is seeking 40,000 enrollees nationwide and should meet that target in early 2021. Two other COVID-19 vaccine studies will be opening to enrollment at MUSC Health in Charleston in January and will offer additional participants the opportunity to take part in COVID-19 vaccine research.

Continuing to offer COVID-19 vaccine studies is critical, according to SCTR co-principal investigator Patrick Flume, M.D., who also serves as the MUSC associate provost for research compliance and regulatory affairs and director of the MUSC COVID-19 biorepository.

Flume said, “The currently authorized vaccines will not be sufficient to provide for everyone, so we must finish the tasks of developing more vaccines. It is important that MUSC be a leader in this space and offer these trials to the people that we serve.”

Studies of this magnitude require collaboration from more than 60 staff members from a number of departments to ensure success and rely on SCTR’s depth of experience in clinical research.

“SCTR comprises an incredible group of talented individuals who are excellent at their jobs and solid team players,” said Kathleen Brady, M.D., Ph.D., SCTR principal investigator and MUSC vice president for research. “This collaborative spirit has enabled our team to respond to the challenges posed by COVID in an exemplary manner.”

Flume is also impressed by the MUSC and SCTR response to the crisis.

“We’ve achieved tremendous results thanks to strong collaboration between highly functioning teams such as those at SCTR, institutional offices such as the Office of Clinical Research, the Institutional Review Board and the Office of Research and Sponsored Programs, clinical research teams and hospital services,” said Flume. “I am so grateful to be able to work with such motivated and talented people.”