In this installment of our series on how the clinical trials industry is responding to the COVID-19 pandemic, I spoke with Dr. Neal Thomas, Associate Dean for Clinical Research for the Penn State College of Medicine. When Dr. Thomas assumed this role at Penn State in 2015, the research program had a single campus. Now the health system has expanded to two hospitals and over 60 clinical sites.
Like many institutions, the initial focus when the pandemic hit was on the safety of patients and staff. The team paused a number of trials, particularly ones that didn’t have a therapeutic benefit or that could put a strain on their reserves of personal protective equipment (PPE), which were needed by their front line medical professionals to care for COVID patients. They also implemented masking and temperature check processes quickly to allow therapeutic trials to continue running.
Soon after, they were selected to be a site for the first phase of the remdesivir trial sponsored by NIAID. Dr. Thomas’s team quickly needed to assemble a team and compress startup processes that would normally take months into a matter of days. “Within 12 business days we had our first patient enrolled,” says Dr. Thomas. “It was an amazing demonstration of flexibility and teamwork to get that trial up and running.”
Communication is Key
The core of what has allowed the team at Penn State to respond and adapt so quickly is a focus on communication and setting expectations. “Everyone needed to be on the same page so that we were all moving forward together, and that we were going to have to do things differently,” says Dr. Thomas. “We set the expectation up front that we can’t do things our normal way.”
Helping everyone understand that things needed to be done differently was crucial, says Dr. Thomas, because everyone was being thrust into circumstances that were far outside of their normal day-to-day. Clinicians that had never conducted research were suddenly in the middle of a clinical trial. Coordinators that were new to infectious disease research and used to working side by side with their principal investigators, were suddenly forced to do their work remotely.
By emphasizing the need for communication and flexibility, Dr. Thomas says the team was able to adapt and support each other through the challenges without losing sight of crucial details. “The devil is in the details. Crossing the t’s and dotting the i’s as you get started is the most important thing. These COVID-related trials are different,” says Dr. Thomas, “Attention to the details of the process are paramount.”
Putting the Right People in the Right Place
Dr. Thomas also had to move around resources to support the significant demands being put on the research team. “Our central offices played a heavy role in the regulatory work of getting these trials started. We redeployed one of our budget analysts, who in her previous life was actually a nurse, a clinical research coordinator, and a regulatory expert, but she’s been out of that role for a number of years. We redeployed her as our regulatory startup person for COVID-related trials. Having her expertise even though it wasn’t part of her current job description, was invaluable.”
Despite being thrown into different roles and responsibilities, the team was happy to step up to support the larger effort, “One thing we’ve seen during this is that people want to do the right thing,” says Dr. Thomas, “and they’re willing to take that extra step to get the work done.”
Preparing for the Unknowns of the Months Ahead
“We don’t know what next week or next month looks like,” says Dr. Thomas, and that is one of the things that’s top of mind as he prepares for the coming months. The pandemic is likely to have far-reaching effects on every aspect of medicine, which will affect clinical research for years to come.
“There’s a good body of literature now about the secondary effects of this pandemic in non-COVID-related diseases. People are putting off treatment for heart disease or for cancer or for other things, because they don’t want to leave their house and they certainly don’t want to go to the hospital. And that’s the unknown that I think we’ll unravel.”
In addition, Dr. Thomas is concerned about the effect that will have on clinical trial recruitment. “There are certainly patients who would be eligible for clinical trials and may have a potential benefit,” says Dr. Thomas, “but may never even came onto our radar because they are delaying their care and their treatment.”
Finally, the tremendous financial impact of COVID on healthcare providers is only beginning to become apparent. Research programs will need to balance the demands of new COVID research alongside their existing research portfolio while under immense financial pressures. “We’re really going to need to figure out what is important for us as an institution moving forward,” says Dr. Thomas. “I think every institution is going to have a different answer to that. We have to figure out what we want to do and what takes priority and figure out alternatives to continue the remainder of the research that is likely going to be slowed by this.”
The Need for Speed and Flexibility in the New Research Paradigm
Within these unknowns, Dr. Thomas sees an opportunity to use lessons learned during these moments of necessity to make clinical trial sites more robust for the future. Dr. Thomas points to a number of new processes implemented during the COVID crisis, such as telemedicine, remote monitoring, patient pre-screening, and e-consent, as areas for permanent improvement moving forward.
“Those are things that we wouldn’t have thought of a few months ago, but now they make perfect sense,” says Dr. Thomas. “That’s one thing that could be seen as a positive to this pandemic, is some things that were on our back burner got pushed to the front burner by necessity.” As research programs assess how they change their processes moving forward, they’ve already proven to themselves that they can implement new processes when needed and they’ve seen that a critical need can come out of nowhere. This could motivate sites to make changes now allowing them to be more agile in the future.
Dr. Thomas also points to adaptive trials as an area of opportunity for future clinical trials. “Adaptive design trials, which were just starting to come into vogue in the last couple years, I think will take forefront in the future. We’ve shown that we can do these adaptive trials and find the answer to one question and then move quickly to another question.” This agility will be crucial, Dr. Thomas says, as the industry looks to run effective clinical trials moving forward.
The world is entering a new research paradigm, where we’ve experienced how our operations can be upended by a crisis and seen the ripples it can create that reach every element of our lives. As we tackle clinical research moving forward, these lessons will be top of mind. The question will be if we maintain the will to make the improvements we know can and need to be made.
I appreciate Dr. Thomas sharing his experience and insights with me. In the coming weeks, we’ll have more installments of our series, sharing a wide variety of perspectives from industry experts on how the clinical trials landscape is responding to and evolving from COVID-19. 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.