In the previous installment of our series, Dr. Christina Brennan from Northwell Health shared how her team managed their clinical trial program in the middle of the first wave of the pandemic in New York. Today we’re hearing from Margaret Ferreira, MS, RN, OCN, Research Program Director for Northside Hospital‘s Central Research Department in Atlanta, Georgia about how her team is balancing oncology and COVID trials during the pandemic and beyond.
Under normal circumstances Northside Hospital’s research staff of 60 employees are running about 200, primarily oncology, trials a year across five hospitals covering a wide geographic area. But when the pandemic hit in March, the entire team had to shift course quickly. “One minute, it was business as usual and then I just started hearing from my staff — surgery stopped, procedures were limited and offices were closing and moving to telemedicine. It just all just came in this flood,” says Ferreira. “First I paused enrollment to a little more than half of our trials. I made this decision based on the guidance that came out from the FDA and the guidance that came out from the NCI. We prioritized which trials would be temporarily paused based on study design. Trials for which there was already a standard of care as an option, were the first to be paused.”
The team quickly adopted remote working policies to continue their support of ongoing research, including staggered schedules where each team member was in the office for two days, and a scanning process to protect PHI while staff worked from home.
Then, the focus shifted to supporting COVID research. Ferreira became the primary point of contact for all COVID research being run across the hospitals, managing her team while working around the clock to effectively spin up new COVID trials.
Handling the Information Overload
One of the significant challenges the team has had to face is the sheer amount of information they needed to process quickly to respond to the pandemic. “That last week of March was a flood of overwhelming information,” says Ferreira.
From a research perspective, the pandemic has been particularly challenging to manage because of the lack of a standard of care for COVID-19 patients. “There are so many unknowns about COVID, that everything needs to be done urgently, but there’s no standard by which to treat these patients, other than treating them with supportive care and some off label medications,” says Ferreira. With no standard of care and a wave of clinical trials being launched, the research team at Northside has been particularly thorough about vetting studies for the organization to take on.
“Now the challenge is that we need to vet studies against what we believe to be our standard of care,” says Ferreira. “But there is no standard so it’s deciding what is the best route for these patients. And with research, just by nature of research enrollment processes, enrolling patients to a trial is going to slow things down. There’s randomization and control groups; eligibility confirmation; drug accountability and oversight; complex care coordination in an environment we have never experienced before. There’s a lot to consider.”
Balancing Speed and New Research
Additionally, the team had to balance a variety of logistical challenges with spinning up their COVID-19 clinical trials. The team slimmed down their normal start-up processes to get trials up and running in a matter of days, identifying places they could shorten and simplify procedures without compromising critical processes. Their goal was to ensure everything was completed appropriately while making the process as simple for the physicians as possible.
This was particularly challenging because the team was working with physicians that weren’t experienced running clinical trials. The research team had to step up, using their expertise to support the physicians while ensuring the research was being done in accordance with the regulations. “A lot of these physicians have never done research before. So, when they’re calling you, and they want convalescent plasma and their patient is, for example, intubated, it adds a layer of complexity to obtaining informed consent. In that case the family member has to consent, but let’s say they speak Spanish. It’s a lot to go through and understand how to obtain informed consent from a patient who is in that situation, and also provide necessary guidance to the treating physician who may not have ever done research before.” She and her team worked with the physicians to ensure key procedures were followed appropriately, without slowing down patient care. They’re now turning those experiences into training materials for the wider team for conducting research in the future.
Preparing for Future Waves and a New (Not So) Normal
With the immediate COVID research up and running, the team is looking at how they can prepare for the future. The first step is to ramp back up their paused trials. “We’re slowly leaning into it,” says Ferreira. “I’m really following the cadence of the hospital, because I don’t want my staff coming in unnecessarily and potentially exposing themselves or others unknowingly.” As the hospitals resume elective surgeries and procedures, they are prioritizing oncology cases, giving the team a chance to continue with their oncology trials.
Ferreira is quick to note, however, that ramping back up existing trials doesn’t mean returning to the way things were. It’s becoming clear that this is just the first wave of the COVID pandemic and future waves are something the industry will have to grapple with for a long time. A recent New York Times article outlines different models for the pandemic over the next two years and all three major models involve multiple spikes in COVID cases.
The Northside team is preparing for that reality. “I envision a tremendous shift in what our whole program is going to look like for the foreseeable future” says Ferreira. “As the COVID cases slow down our oncology cases will ramp back up, but then I envision a shift back again to more of a COVID focus in the fall and more pausing with oncology.” It is a challenging new paradigm the entire clinical research industry will need to adapt to in the coming months and years.
Becoming More Nimble as an Industry
Ferreira’s biggest takeaway from the pandemic so far is that the entire clinical trials industry has proven its ability and the importance of being more nimble. In an industry known for detailed processes and timeframes lasting years, the ability for sponsors, regulators, researchers, and clinicians to start up studies in a matter of days has been astounding. But it highlights the fact that non-COVID research can likely be conducted faster as well.
“We’ve seen that the FDA is very capable of pushing things out quickly,” says Ferreira. “I’ve seen people amass and come together and create very useful guidance for us in the industry. So I can see that it’s possible and the pandemic has really removed a lot of that red tape that we’ve seen historically. I’m hoping that we learn from this that we have a lot of layers built into research that may not be necessary.” This could be a beginning of an industry-wide conversation on how accelerate clinical trials to cope with the current environment and help get treatments to patients faster across all areas of research.
As we head into this next phase of the COVID pandemic, Ferreira is concerned for the patients on her oncology trials. “Oncology patients are especially at risk being such a vulnerable population,” says Ferreira. “and there are still so many unknowns right now.” Through it all she remains focused on her core goal: “keep your patients safe, keep your staff safe, and do the best you can.”
I can’t thank Ms. Ferreira enough for discussing her 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 thus 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.