The research world’s axis shifted in 2020 with the COVID-19 pandemic. Research organizations and IRBs should expect that shift to be the new normal. There will be no return to the way it was before.
“Many of us looked at what research would look like in 2030, and I think the pandemic has forced us to do that now,” said Christina Brennan, MD, MBA, vice president of clinical research at Northwell Health in New York City. Brennan spoke at a WIRB-Copernicus Group (WCG) web conference on July 8.
“Many of us in the industry have had [pre-COVID-19] conversations about virtual visits and remote monitoring visits,” Brennan explains. “I see this [pandemic] as a challenging opportunity in this new environment about how we conduct research.”
Research organizations quickly learned how to continue studies during the pandemic. Now, they are considering how to continue these changes in the post-COVID-19 world. “How can we help our [study participants] feel safe in clinical research in a remote environment?” Brennan asked.
Focus Shifted to COVID-19
When the nation first shut down during the pandemic, research sites put many studies on pause and mandated telework policies, sending research staff home. But their focus shifted as researchers began seeking COVID-19 studies.
“We started with an expanded access program. This entry into research to get a study opened very quickly,” said Erika Siegrist, MS, RN, ACRP-CP, director of research administration with Anne Arundel Medical Center in Annapolis, MD. Siegrist also spoke at the July 8 conference. “We took all of the staff we had in research and reassigned everybody.”
First, the organization focused on access protocols and placed staff on the side of plasma donor recruitment. “It worked well for us to have our own product and blood supply,” Siegrist explained. “As we went along, we did a lot of reassigning and redeploying.”
Oncology studies were put on hold at first, but the organization kept much of its portfolio open. “With our staffing, we’ve been extremely flexible,” Siegrist added.
By July, the organization resumed elective surgeries and had staff return to clinical trials. “We worked on the logistics of doing ambulatory outpatient trials,” Siegrist said.
Clinical trial sites started transitioning to the post-pandemic world by making triage decisions on studies.
“We had to decide which trials to keep open — those patients actively receiving medication, and those we had to turn into virtual visits conducted by telephone,” she said. “We had to decide on the best way forward, and we had to discuss remote monitoring. We were able to conduct research while this was going on.”
The research organization allowed only remote monitoring visits with active trials, providing monitors with full electronic health record access. “To this day, we have not allowed monitors to come back into our hospitals and outpatient facilities, so we are continuing remote,” she said.
While research organizations and IRBs dealt with changes pertaining to their pre-COVID-19 trials, they also made decisions about new studies into SARS-CoV-2 treatment and vaccines. “The COVID clinical trial unit and we had to decide which trials we would participate in,” Brennan explained.
“As it relates to COVID-19 trials, the new norm is these will go on for a long time,” noted Molly Hair, director of site engagement and management with WCG ThreeWire of Princeton, NJ. Hair spoke at the July 8 web conference. “What has worked for us in the past three months is not necessarily what will work once all the non-COVID studies start up again. One thing many institutions and sites do is they operate with designated COVID contact teams — a select group of people who are designated to physically interact with patients diagnosed with COVID. Often times, these teams are external to the clinical research department.”
Personal protective equipment may be limited, or there could be concerns about infection prevention and maintaining consistency in studies when staff might be home sick or quarantined for limited periods. “There can only be so many people interacting at a given time,” Hair said. “It can also cause issues when there is a surge in hospitalizations because the number of individuals allowed to contact COVID patients are stretched thin and can lead to deviations in blood times and other procedures mandated by the protocol.”
Some Studies on Hold
Non-COVID-19 studies may be placed on hold or restructured to supplement study teams. “Once a non-COVID study starts back up, and the supplemental staff returns to its prior role, study teams are left understaffed. Many sites have hiring freezes,” Hair explained. “What complicates this is the second wave. Sites don’t want to hire additional staff members to fill those vacancies if a second wave is going to come, and then they have to revert back to the structure that has worked for so many sites over the past three months.”
This leaves research organizations with extremely difficult staffing decisions. They need more staff to prepare for returning to full pre-COVID-19 trials, plus the new COVID-19 studies. But they also have to prepare for possibly shutting everything down again. “Complicating this further are the demands of data entry and query information that comes with COVID trials,” Hair noted.
With COVID-19 studies, sites cannot allow a backlog: “Sponsors are requiring data to come in 48 hours past the point of collection,” Hair said. All these decisions require conversations between IRBs, sponsors, and scientists, she says.
Establish Trust with Participants
For trials where in-person visits are necessary, clinical trial sites and IRBs should consider how patients/participants feel about making these visits in the backdrop of COVID-19 outbreaks and surges.
“Patients are very anxious about returning to doctor’s visits to the sites,” Brennan said. “If you think about clinical research, it can become part of the norm and conversation. There are ways we can help each other bring our research visits back.” IRBs and research organizations might decide in-person meetings are relics of the past, and continue with virtual meetings, she added.
Research participants need to trust and engage with clinical trial sites. Researchers should consider how participants would feel about participating in clinical research in this environment, Brennan noted.
“Also, think about safety precautions,” she said. “Patients should wear masks, employees should wear masks, there should be temperature checks, social distancing, and all of these things should continue to occur in this new environment.”
The key is to think about these things in a solution-oriented framework.
“We have to put these processes in place to continue in clinical research and perhaps shift the paradigm in how we conduct research,” Brennan says.