COVID-19 Disrupts Clinical Research Studies

March 22, 2020
FDA issues guidance as researchers are forced to weigh benefits vs. risks to participants and research staff

The pandemic’s impact on health systems extends to the realm of clinical research trials, with researchers attempting to weigh the risks and balances of continuing or halting particular studies.

Adrian F. Hernandez, M.D., M.H.S., vice dean for clinical research at Duke University School of Medicine, called the issue “pretty daunting.”

Speaking during a meeting of the NIH Collaboratory Grand Rounds on March 20, Hernandez gave a sense of the magnitude of the problem. “In the United States, there are almost 20,000 active studies that are recruiting, and around the world, over 50,000,” he explained. “You can imagine the millions of participants around the world for whom there are important answers needed for addressing health problems, but to do so in a safe and effective manor is going to be a big stressor on the whole system.”

Over the last several weeks multiple research sites, sponsors, and funding agencies have been trying to address these issues. They are asking whether they should keep enrolling or modify protocols. “How can we do this in a very rapid fashion without administrative burden?” Hernandez asked. “People are being overloaded in all sorts of ways — from IRBs to study staff. You have participants joining a study to contribute something around their health problem, who now have other issues to worry about. What do you do with this major disruption where data could be adversely affected by COVID-19?

The U.S. Food and Drug Administration came out with guidance this week, he said.

 Noting that all trials will be impacted by COVID-19, the FDA said that contingency measures should be implemented during the disruption to ensure the safety and well-being of participants. The FDA also said studies should have corresponding plans to understand data that may be generated from this period.

“We will see how people address these problems,” Hernandez said. “It is a broad set of issues in terms of balancing benefit and risk. There are certain high-risk conditions where providing access to protocols is very important. You can imagine a number of cancer studies where there are no reliable effective and safe alternative therapies. Participating in a trial may offer access to something that can have potential benefit. Just turning those off may have greater direct individual impact. But there is the need to balance risk to participants and the research staff. It is not an easy set of benefits and risks to address.”

 At Duke, he continued, they are tiering studies into three categories. One is essential studies with high potential direct benefit — for example, a cancer study for which there is no alternative treatment. A second tier might provide moderate potential benefit not in the acute term, but perhaps in the longer term. A third tier is considered non-essential. These are primarily observational behavioral studies without potential direct benefit to participants. “You can see there are all sorts of ethical issues to consider,” Hernandez said. “Some organizations are allowing access to essential studies that have the clearest direct potential benefit that would be considered life-saving, while other studies suspend enrollment and do as much work virtually as possible.”

 Even before the pandemic, there has been conversation about the need to have research at home, because it can be more personalized, streamlined and valuable. “COVID-19 illustrates the need to have systems in place in which you only come into the healthcare system for the things you directly need as a site and try to do as much as possible at home and be more participant-friendly.”

 Susanna Naggie, M.D., associate dean for clinical research initiatives and regulatory affairs at Duke University School of Medicine, also spoke about how quickly things have changed in terms of guidance for research teams. “Less than two weeks ago, we held a town hall meeting, with  guidance from Duke Health System. At the time we had 13 confirmed cases in North Carolina. We had all studies still actively enrolling, but pre-screening was required to identify folks who needed to have a mask or any triage. We had no restrictions at that time on visitors and we were providing guidance to people on symptoms if we picked those up. Staff was told to avoid meetings of 50 people or more.

Speaking on March 20,  Naggie said that earlier in the week there were 133 cases in North Carolina. Duke has now enacted the Essential Clinical Research Study Policy, which means they are suspending all in-person activity for any clinical research study that was not essential to the health of the participant.  The health system had begun to screen at the door of every person walking into the health system, and patients are only being allowed one visitor. “We have travel limitations, and every meeting is going virtual,” she said.  

“What is concerning for us is that the current trajectory puts the United States on track with Italy, and that is not something we want to see reproduced here in the United States,” Naggie said, “so we want to play the right role in limiting this as much as possible by following our public health service recommendations.  The question is, what is essential from a research perspective? When do we make decisions about halting in-person enrollment? We have to consider the risk we are asking our staff and participants to take when we are asking them to present in person.”

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