March 21, 2020 – The coronavirus outbreak has limited in-person research, highlighting the need for more flexible, participant-friendly research models that can be conducted virtually.
DCRI faculty Adrian Hernandez, MD, MHS, and Susanna Naggie, MD, along with Duke Forge’s Eric Perakslis, PhD, spoke yesterday at an NIH Health Care Systems Research Collaboratory Grand Rounds webinar about how clinical research has been and will be affected by the COVID-19 outbreak.
The outbreak is moving rapidly, with confirmed cases in North Carolina increasing from 13 to 133 in about two weeks, said Naggie, Associate Dean for Clinical Research Initiatives and Regulatory Affairs for Duke University School of Medicine and director of the DCRI’s Infectious Diseases therapeutic area.
Those conducting clinical research have to consider what is essential from a research perspective, Naggie said. “We have to consider the risk staff and participants take when we are asking them to present in person,” she said.
There are currently almost 20,000 active studies in the U.S. and more than 50,000 active around the world, said Hernandez, Vice Dean for Clinical Research for Duke University School of Medicine, with many of them seeking important answers outside of COVID-19. “To (conduct these studies) in a safe and effective manner is going to be a big stressor on the whole system,” he said. He pointed to guidance released by the FDA this week on how to implement contingency measures during the outbreak to ensure the safety and wellbeing of research participants.
To help stakeholders define which studies are essential, Hernandez outlined a tiered system. Studies may be considered Tier 1, or essential, when no alternative therapies exist and discontinuing the studies would have a negative health impact. Tier 2 studies may have a moderate potential benefit for participants, although this benefit may be more long-term than acute. Tier 3, or nonessential studies, are primarily observational or behavioral studies with no direct benefit to participants.
As of March 16, Duke University School of Medicine implemented its Essential Clinical Research Study Policy, which temporarily suspends all in-person activities for non-essential studies. Virtual study activities are allowed to proceed.
The outbreak illustrates the need for new, participant-friendly research models, Hernandez said, in which participants are only required to come to the clinic for care they already needed and the remainder of their research participation can be completed at home.
Perakslis, a Rubenstein Fellow who has experience working in the Ebola outbreak, spoke about data considerations that would help health systems learn from this outbreak and be better prepared for the next one. A standard case report form across health systems would help improve both research and care, and the ultimate goal would be to implement a telehealth-based learning health system in which learnings could be implemented in real time.
Considerations for research will certainly continue to shift as the pandemic continues, Naggie said. For example, if doctors, nurses, or other staff with clinical training currently engaged in research are redeployed to care for patients, this will also change decisions made about how to proceed with research projects.
To learn more about the discussion, visit the NIH Collaboratory website.