Advice from Vanderbilt on Reopening Clinical Trials During COVID

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As the initial onslaught of the COVID pandemic levels out in some places, hospitals and research organizations are focusing to how to reopen and run clinical trials in the new normal. For the next installment in our series with industry experts discussing how to conduct research in a COVID world, we hear from Brian Rini, MD from Vanderbilt University Medical Center.


In January of 2020, Dr. Rini joined the Vanderbilt-Ingram Cancer Center (VICC) as the inaugural Chief of Clinical Trials, overseeing trial operations with a focus on increasing participation in high impact clinical trials for patients with all types of cancer. Within weeks of joining the team, the COVID pandemic hit. In the following weeks, Dr. Rini’s focus shifted entirely to COVID-related research, trying to determine how to safety continue trials and reorient resources to prepare for a potential wave of COVID cases.


At first, the team shut down as many trials as they could to protect patients and preserve resources. “We weren’t sure that the doctors would be healthy enough and wouldn’t be in an ICU running a ventilator,” says Dr. Rini. “So just from a human resource perspective, we had to think about the fact that if half the doctors were sick and the other half were doing ICU-type care, then there wouldn’t be doctors available to take care of the patients in our trials.”


Once it became apparent that Nashville wasn’t going to be hit as hard as places like New York City, Dr. Rini and others had a chance to step back and take a larger, more strategic look at how to handle clinical trials moving forward. He shares his perspective and advice for institutions looking at how to run clinical trials and conduct good research in our current, incredibly challenging, environment.


Reopening is Harder Than Shutting Down


“It’s much easier to shut everything down than it is to reopen,” shares Dr. Rini. “Opening back up is more logistically challenging because we can’t do it all at once. We have to be aligned with the city and the institution. There are several parties that need to be organized and things just move more slowly.”


During the early weeks and months of pandemic, the organization had tried to maintain momentum for trials that were in the early stages of planning and startup, making it easier to launch them when the time was right. “If trials were early on, we continued working on them, getting them up to the point of opening and then pausing them,” says Dr. Rini. This gave remote staff projects to work on that also kept the organization prepared to restart research quickly.


Dr. Rini encourages organizations to empower disease teams with as much autonomy as possible during reopening. “I worked with our disease team leaders and said ‘You know your portfolio and protocols and what’s important. Give us a wish list of what you want to reopen.’ And most of that we were able to reopen.” By empowering disease leadership in the organization and not forcing top-down decision-making, he’s creating an organization that is more nimble and capable of responding as the pandemic evolves and needs change.


The team also wanted to preserve many of the new processes that were implemented during the early months of the pandemic, such as telehealth and shipping drugs to patients. Working those processes into the existing workflows and regulations of the organization takes time and consideration, but is worth the effort to make the clinical trials program more prepared for future waves and more convenient for patients.


Implement the Necessary Precautions


As the institution resumes clinical trials, they’ve instituted a myriad of safety precautions to ensure research can be conducted safely for the long term. This includes mask requirements, temperature screenings, social distancing, sanitization practices, and screening of asymptomatic patients receiving high-risk regimens to ensure early detection of COVID cases. This screening extends to testing all patients that are starting certain cancer regimes, whether as part of a clinical trial or not. This is part of an effort to not only keep the patients safe during aggressive treatments, but also keep the staff safe as they treat vulnerable patients.


Take This Opportunity to Re-invent Yourself


Dr. Rini encourages institutions to take this opportunity to step back and assess their strategy for their research portfolio. “It’s a chance to reinvent yourself, to think about how you do trials and how you can be efficient with your portfolio,” says Dr. Rini. “It’s given us a chance to look at trials that weren’t accruing well or were underfunded and say, do we really need to open these trials again? It really forces you to take a hard look at everything you’re doing and make sure that it’s aligned with good patient care, good science, and maximal academic credit — all the reasons that we should be doing research.” Many institutions expand their research over time and don’t take time to pause and identify research that isn’t serving the larger goals of the team or institution. “There’s opportunity here to make changes for the better, even though it’s difficult while we’re going through it,” says Dr. Rini.


Find Ways to Integrate COVID with Ongoing Initiatives


COVID isn’t going away any time soon. Institutions have the opportunity as the pandemic continues to integrate COVID research into their other ongoing priorities and initiatives. For example, Vanderbilt has built a database of thousands of patients who have cancer and COVID. This will allow them to conduct crucial research on the interplay between these two diseases in the months and years ahead, contributing crucial new information to our evolving understanding of COVID.


Consider the Patient Perspective


While implementing these changes and new processes, Dr. Rini encourages leadership teams to never lose sight of the patient perspective. “Clinical trials are often anything but convenient for patients,” says Dr. Rini. Many patients are nervous about coming into medical centers right now due to a belief that they’re dangerous due to the pandemic. While that objectively isn’t the case, Dr. Rini points out that perception is reality and hospitals and research staff need to be aware of how patients might be perceiving the situation in order to proactively address and mitigate their concerns.


Overall, Dr. Rini is glad to see widespread appreciation for everyone involved in making healthcare institutions run on a day to day basis. “It’s nice to see healthcare workers getting appreciated. And not just the doctors, but nurses and the staff who clean the rooms and everyone else involved,” says Dr. Rini. “It makes you feel good about what you do and that people are genuinely appreciative.”


Thank you to Dr. Rini for sharing his advice and perspective. As we continue this series we’ll share more inspiring and valuable stories from teams conducting clinical trials on and during COVID-19. Join our newsletter to receive future installments of this series. If you know a team whose story I should share, please email me. Stay well.



About the Author: Emily Hossellman


Emily Hossellman HeadshotEmily 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.




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