Even with the looming possibility of a “second wave” of COVID-19 cases striking in the near future, clinical trial sponsors and sites are trying to see their way clear to how new or resumed non-COVID-19 studies can best be conducted alongside those tied to the coronavirus, which could be hogging much of the research bandwidth at many institutions in the long term.
Speakers taking part in the latest entry in WCG’s webinar series on COVID-19-related research challenges yesterday (July 8) held out hope that lessons being learned during the pandemic—in terms of flexibility and scalability of study staffing—will be translated into actionable strategies for thriving in just such a dual-priority environment for some time to come.
Christina Brennan, MD, MBA, vice president of clinical research with Northwell Health and member of the Association Board of Trustees for ACRP, said that while many positive advancements were quickly implemented at Northwell for virtual patient visits and electronic informed consent, “Still to this day, we have not allowed our monitors to come back to our hospitals or out-patient facilities.”
With remote monitoring thus being a given and some new or delayed studies recently being opened, “I see [the pandemic] as a challenge, yet an opportunity, in this environment for how we will conduct research,” Brennan added. “We really need to think now more than ever how a patient feels about participating in research. We really need to think about things in a solution-oriented framework—not just how things should be done,” but putting the processes in place to make them happen.
Erika Siegrist, MS, RN, ACRP-CP, director of research administration for the Anne Arundel Research Institute of the Anne Arundel Medical Center, described how flexibility in research staffing there allowed staff to be reassigned from oncology and surgical studies that had been put on hold to new COVID-19-related projects.
As the institute expanded beyond its typical in-patient trials, “we worked on the logistics of doing out-patient ambulatory trials,” Siegrist explained. COVID-19-positive out-patients participating in trials will now be seen in a “field hospital” tent located outside the medical center’s main buildings and completely staffed by clinical trials personnel, she added.
“We’ve got a goal and a vision on what we want to do, which is keeping staff safe [and] providing care options” for trial participants, Siegrist said.
Molly Hair, director of site engagement and management for WCG Threewire, cautioned that with so many site-based research staff across the country who had been on non-COVID-19 studies that were delayed now being tasked with COVID-19 studies, new hiring may be necessary as the previous studies restart and new ones launch. This would especially be the case if a second COVID-19 wave hits and staff are again shifted, but now leaving the ongoing non-COVID-19 trials perilously understaffed, she noted.
“All of these issues related to flexibility and scalability of staffing—and data and query resolution demands—require that sites start to think about how to provide supplemental staff that, frankly, may come from outside their current employee roster, and that funds are spent on that effort,” Hair advised, “…even in the face of budget restrictions and drastic reductions in revenue for sites all around the United States.”
Author: Gary Cramer
