In this installment of our series on how COVID is affecting clinical trials, I’m speaking with Cedron Williams, director of the office of clinical trials for East Carolina University (ECU) in Greenville, North Carolina. At any given time, ECU’s Brody School of Medicine has between 150 and 200 actively recruiting clinical trials, representing multi-disciplinary collaborations with academic, industry, non-profit, and government entities. Williams shared how ECU is playing to its strengths to manage all types of research during the COVID-19 pandemic.
Building a Plan
In January, the team at ECU started hearing buzz about a potential pandemic and began gathering as much information as they could to prepare. When the COVID pandemic hit in March, many hospitals immediately paused or slowed down their clinical trials. ECU took a different approach, aiming to keep as many of their trials open as possible.
“We didn’t want our plan to be restrictive to the point that we’re shutting down our lifeline, because research is what’s going to be driving the solution,” Williams said “So where other institutions are shutting down their research programs, we did the opposite. We’re saying we want to keep research and clinical research opportunities going. We as an institution are going to make that stance, that we want to engage researchers and scientific personnel to help come up with some of these solutions.”
While the institution did shut down a significant amount of research to protect the safety of subjects, patients, and staff, the organization wanted to continue running critical research that had substantial benefits that outweighed the risks. The team could take this approach due to a combination of planning and being in the fortunate circumstance that their area wasn’t hit as hard as some other parts of the country. A significant proportion of their population is rural, which has given them two advantages during the initial stages of the pandemic: time and space. And the team at ECU isn’t squandering that.
The research team is working in tandem with clinicians as they prepare for a wave of future cases. “We are working very carefully alongside our clinical personnel and our providers,” says Williams. “We think that research really shadows the clinical care, it doesn’t dictate clinical care.” They are focused on supporting the preparation efforts of clinicians and integrating their research protocols into the plans for future waves, to support both research and clinical care in sync.
Another distinct approach the ECU team has taken is to decentralize decision-making and empower research teams to make their own decisions on how to adapt their research. “A lot of our scientists work in teams and often those scientific teams are self-identifying and self-forming. Those decision makers and key personnel need the latitude to come up with solutions,” says Williams. “So we created somewhat of a loose plan to allow the decision–making to be led by the team and the investigators.”
Williams and his team outlined a four-phase structure that provided general safety guidance, with phase zero being normal operations and phase three being the most restrictive. The hospital is currently working in phase two, with plans in the works to return to phase one. This has given the team the ability to continue with critical research, while also launching select COVID trials.
Leveraging Telemedicine & Remote Monitoring
Beyond the general philosophy, ECU had a few logistical advantages to leverage, in particular a previous investment into programs for telemedicine and remote monitoring. Given the wide geographic spread of their patient population, telemedicine and remote monitoring have long been a necessity for ensuring patient care and compliance. “As a rural institution we had, for the sake of being able to survive, a very strong telehealth medicine program,” says Williams. “And now, to include it in our COVID response is very helpful because they can utilize that same platform.”
Williams points out that, in an era of social distancing and equipment shortages, there are likely other ways more urban institutions can learn from hospitals with experience serving geographically dispersed populations, like his. “The people that drive an hour just to go to the doctor or go to the academic centers to seek treatment, that’s an area that we can really hone in terms of practices because it takes you to an area of the spectrum of those who are doing a lot with the basics,” says Williams. “If we can replicate that in a systematic approach, then we can address some of these challenges in urban areas where these hospitals that are having hundreds and hundreds of patients with COVID.”
Williams firmly believes that our best path through this time is to share information and work together to uncover solutions and save lives. “This conversation is really, really important for various communities of researchers and scientists to start engaging in discussions. This process is going to be strengthened by that discussion, sharing ideas about best practices and processes, of what things are working when things aren’t working. These conversations, just like ours, is going to be extremely helpful.”
I appreciate Mr. Williams sharing his experience and insights with me. In the coming weeks, we’ll have perspectives from a variety of different experts on the lessons they’ve learned during the pandemic so far and how they think the clinical trials landscape will be affected. Join our newsletter to receive future installments of this series. If there is a question you’d like answered in our series or you’d like to be featured in a future installment, please email me. Stay well.
About the Author: Emily Hossellman
Emily Hossellman is the vice president of marketing at Deep 6 AI, which uses AI and NLP to allow clinical researchers to find patients that fit any set of complex criteria in real time. Emily partners with Deep 6’s customers and other industry experts to share their success stories on how they’re using technology to conduct innovative clinical research. Emily has spent her career in cutting-edge technology, working with consumer electronics, IoT, smart building, and artificial intelligence products. She’s a frequent writer and speaker on the disruption, transformation, and opportunity afforded by new technology.