By Melinda Young
The big question in the clinical research world is how things will look when the COVID-19 pandemic has ended. Will everything go back to the way it was? If not, what changes will remain?
“I don’t think we’re going back to the old normal,” said Alison Lakin, associate vice chancellor for regulatory compliance at the University of Colorado Denver, Anschutz Medical Campus. Lakin spoke about COVID-19 at a WIRB-Copernicus Group (WCG) web conference on April 8.
“We’re living in this era of potential waves of disease that will impact us nationally, regionally,” Lakin said. “There may be the need to have some continued social distancing, whether continuous or intermittent, and we’ll need to manage the unpredictability of hotspots coming up.”
Research enterprises should think about how they will ramp up operations in a less stable world. “They should be aware of local context, and sponsors knowing what that context is will be really important,” Lakin said. “Different sites will be opening in a different time than other sites.” IRBs and research organizations need to understand the limitations of basic resources they previously had taken for granted, she added.
“We are not going to return to normal,” noted Jill Johnston, president of study planning and site optimization at WCG. Johnston also spoke at the April 8 web conference. “It will be a new and improved normal. There is more acceptance of virtual trials and telemedicine.”
The pandemic is transforming the way the human subjects world thinks of virtual clinical trials and patient visits. Practices are changing as well. “I’m not sure what the long-term impact will be, but there is a need for flexibility,” Johnston said.
IRB Meetings Going Virtual
In a post-COVID-19 world, some patients will not want to go back to face-to-face interaction for every trial visit. IRBs and researchers will need to think about that in the future, Johnston added.
IRB meetings have moved to virtual space, and this change might remain after the crisis ends. For example, the University of Cincinnati IRB holds only remote board meetings now, explained Michael Linke, PhD, chair of the University of Cincinnati IRB, and adjunct professor of medicine at the University of Cincinnati College of Medicine. “After two or three meetings, it’s working well, and we may use that process more moving forward,” Linke said.
Now that people are forced to attend virtual meetings, they have experience in doing it and can see how well it works, he noted. “Maybe it’s working better than people thought it would,” Linke said. “It’s hard to change people’s behavior unless they need to.”
The University of Cincinnati IRB uses web conferencing technology that allows board members to use webcams. “More people are using that now than they did before, and I think that makes the meetings better — when you can see people,” Linke explained. “We have probably 12 people at the meetings.”
IRBs also have learned a great deal more about disaster planning because of the pandemic, noted James Riddle, MCSE, CIP, CPIA, CRQM, vice president of institutional services and strategic consulting at Advarra in Columbia, MD.
“Everyone should have a disaster plan in place so that staff and IRB members know what to do in the event you can’t have normal operations — when it could be from flooding, earthquake, fire, or pandemic,” Riddle explained. “Have some emergency plan in place.”
Pre-pandemic, Advarra’s operations already were electronic. “We were able to make the switch to remote work very easily,” he said. “All of our board meetings are held virtually.”
IRB meetings for WCG included board members calling in and participating remotely before the pandemic. Now, the IRB is on a completely remote model, said David Borasky, MPH, CIP, vice president of IRB compliance for WCG. “The regulations were written in an era before the idea of doing things remotely was even thought of as being possible on a regular basis.”
Regulators have welcomed remote meetings. Although some IRB leaders thought federal regulations favored videoconferencing over phone conferencing, that was never the case, Borasky explained. “You don’t have to be in the same room or videoconferencing to have an IRB meeting.”
The IRB operations shift toward electronic records, submissions, and reviews also might accelerate after COVID-19.
The University of Cincinnati IRB has worked from home during the crisis, Linke noted. The IRB office uses an electronic program that allows staff to set up groups for texting and videoconferencing, making it easy to hold staff meetings. IRB coordinators also can set up a group with investigators, Linke explained. “Each IRB coordinator has a certain group of investigators from the same field, and the investigators call them when they have questions.”
Electronic group meetings and messages can be more efficient than email because there is less possibility of someone missing a memo or conversation. This method could continue post-pandemic, even when IRB staff return to the office.
It is likely that IRBs will continue to see clinical trials that hold all or most visits remotely in the post-COVID-19 years.
“One thing we’re going to see change longer-term is that the pandemic is pushing studies urgently to use remote technology like teleconferencing and videoconferencing instead of in-person studies,” Borasky said. “What we may see when we return to ‘normal’ or get through the critical part of the pandemic, and new studies start to open again, is that those technologies can be useful. Investigators and participants both like them, and there may be greater adaptation of those virtual technologies going forward.”
The pandemic might be the tipping point that pushes clinical research to remote and virtual technologies, Borasky added.
During the crisis, sponsors and researchers are exposed to the idea of performing virtual activities in clinical trials, and they might like to continue with virtual visits post-pandemic, Riddle noted. “There’s a transition we’ve been seeing of virtual activities being integrated into clinical trials. Most likely, this crisis will accelerate that process,” he added.
“The utilization of virtual trials will increase access to people who were not able to get visits before,” Riddle explained. “Remote visits or in-home visits really expand the number of people who are potentially able to participate in clinical trials, when before, they couldn’t take the time to get to the clinic.”
The key in making these changes is documentation. “If the research team is going to switch from taking blood pressure in house to relying on blood pressure coming off the iPhone app and recording it, then they need to document those changes. But they do not need approval from the IRB during the crisis unless it increases risk to participants,” Riddle said. “If it’s a permanent change, then submit those changes to the IRB.”
In addition to virtual visits, studies also have changed from in-clinic visits to home visits, Riddle said. For studies that need to continue with in-person visits, some sites are spacing out appointments so there is time to disinfect after each person comes to the facility, he added.
Sociobehavioral research also has changed. “Any studies involving in-person contact had to be changed to remote,” Linke said. “A lot of them involved in-person interviews, and these were switched, easily, over to some type of [videoconferencing] interaction. The interesting thing will be to see how many people will stick with this once they see how easy it is.” Other sociobehavioral studies were put on hold because they involved researchers entering schools, he explained.
The University of Cincinnati IRB issued guidelines for biomedical studies. “We sent out guidance on which studies should be discontinued, which would potentially continue, and a set of criteria for evaluating these,” Linke said. “For instance, it’s like not having people utilize resources, including personal protective equipment, that are needed for the outbreak, and how to limit interactions and screen people for exposure or possible infection before they come in for a visit.”