Clinical Research Through the COVID-19 Pandemic: Crisis Response, Consequences and Innovation

Usually, I am a dual trained open and endovascular neurosurgeon. While working at a prominent academic medical center in New York City, my main focus has always been clinical care first. This all changed at the beginning of March 2020, when our city became inundated with patients severely ill with COVID-19. The health system had to restructure to manage the load, and elective surgeries were canceled and stayed canceled for 3 months while we collectively pivoted primarily towards managing the pandemic.

The research that I had done in the past primarily involved large dataset outcome studies for patients with brain aneurysms or acute ischemic stroke. We had a small team of very capable persons who were adept in curating electronic data from electronic health records. At the beginning of March, many of the early reports were coming in of COVID patients suffering major strokes and other neurologic symptoms. In the middle of March, with a large portion of my usual clinical activity suddenly restricted, we jumped into action designing a retrospective-prospective observational cohort study to try to identify which COVID patients were at risk for developing neurologic manifestations. In order to properly conduct this research, our group needed information on all COVID-19 patients presenting to our health care network.

We were one of the first research groups in our system to submit an IRB protocol, and thankfully through the major healthcare restructuring, the IRB stayed open. At the time, our local IRB had given utmost priority to COVID-19 related studies. These submissions were given immediate attention and the turnaround time on approval was quite rapid, particularly as it pertained to noninterventional observational studies. The rapidity of our approval gave us a head start and access to invaluable resources within our data warehouse group, which was able to ping us all the patients we were investigating with COVID-19. Probably about a week or two after starting, access to this data became restricted as nearly every research group in the system was having similar ideas. There were also growing institutional concerns about the public health message they were trying to portray, layered with the fear that outcomes in certain areas of New York City appeared worse than others. No one wanted to be considered the system that was doing a bad job managing the pandemic or their patients.

In tandem, it became apparent that many other clinician researchers wanted access to similar information. A counterpart in the Department of Neurology and I teamed up to create a research network of interested researchers who wanted to have access to information on COVID-19 patients. We were able to use Microsoft Teams as a centralized hub to help create networks of research groups for parties with similarly aligned research interests while also preventing overlapping research ideas. We could assign roles within specific projects and defuse any potential squabbles about authorship. As researchers expressed interest, we were able to easily addend our IRB to add additional team members with nearly same-day feedback. By the end of the project, there were over 50 researchers involved with various observational projects with clinician researchers looking at a variety of topics including COVID and ischemic stroke, COVID and hemorrhagic stroke, COVID and epilepsy, COVID and encephalopathy, COVID and race/ethnicity, and COVID and neuromuscular disease. While Teams was the hub for our centralized research machine, it was important to keep it maintained and protected and to ensure no patient information was placed in the group. This, in addition to managing the projects and making sure everyone who wanted to be involved was included, became a large part of my job during the months of April and May. We used RedCap to maintain the protected patient information in a database and monitored access to it to ensure compliance. The effort to maintain compliance could not have been done well without the invaluable work from our research team, including our research coordinator and research nurse.

During this time, the IRB deftly maneuvered and created new action items within the IRB submission process. These action items highlighted the specific...