Hackensack Meridian Health’s (HMH) network of 17 hospitals was hit hard by the first wave of the COVID pandemic. As we mourn the grim milestone of 100,000 deaths from COVID-19 so far, we look at how their team combined strong leadership with selfless teamwork to conduct vital research during the early weeks of the pandemic, and what other research institutions can learn from their approach.
Eight members of HMH’s team were kind enough to share their experiences with me for our series, and the themes of their experience were clear: this is a crisis unlike anything we have ever faced, the world is changing forever, and if we support and learn from each other, we will be stronger as a result.
HMH had their first COVID-19 patient the first week of March. By mid-March, the entire organization was all hands on deck to support the COVID response. The Office of Research Administration, led by Chief Research Officer Dr. Ihor Sawczuk, had to quickly rise to the occasion. They recognized that without a known treatment or cure for COVID-19, clinical trials were going to be a key way to get options into the hands of clinicians and patients, who were growing more desperate as the cases increased in number and severity.
Creating a COVID Research Steering Committee
The research leadership at HMH quickly mobilized to create a structure and support system for such a significant research undertaking. In mid-March, Dr. Sawczuk organized a COVID-19 Research Steering Committee. The committee’s charter was to act as a central body to review all COVID-19 research projects to help the institution manage resources and balance competing projects. “We recognized very early that we could no longer do business as usual in the research world,” says Dr. Sawczuk. “We had to focus our teams around COVID-19, get some really smart people in the room and ask them ‘what areas should we be invested in?’ because you can’t do everything.”
The committee started small, but over time came to include representatives from all therapeutic areas and functions of the hospital. “It included every aspect of specialty, such as pharmacy, critical care doctors, neurology, oncology, and cardiology,” says Sergio Garcia, Clinical Research Business Manager. “It really encompassed perspectives from every potential area of complication a patient might have and how these trials can help them.”
In late March, the team opened an online portal where researchers could submit proposals for their COVID research projects. Within 48 hours, they received 69 proposals. The committee was able to review the proposals and identify projects with similarities, connecting researchers across their network to combine their efforts. The steering committee was also able to vet industry and government trials, balancing the needs of those trials with investigator-initiated studies and ensuring the institution could effectively conduct all the research taken on during the chaotic early weeks of the pandemic.
The team at HMH considers the steering committee and the leadership of Dr. Sawczuk to be a key factor in how successful they were in ramping up clinical trials in the early weeks of the pandemic. It ensured equitable access to clinical trials for patients and appropriate resource allocation for the entire organization. In less than two months, the team was able enroll over 800 patients on COVID-related trials, many more than what they would normally enroll in trials in an entire year.
Centralizing Trial Operations
With decision-making centralized with the steering committee, the team also recognized the importance of centralizing trial operations as much as possible. Many clinical trial organizations have their teams siloed, with resources specific to a department, program, or therapeutic area. The team at HMH, despite having such a large network, saw the value in having a central office of research administration. The pandemic gave them a chance to leverage that centralized structure to further pool the network’s resources.
The team set up a research hotline for screening patients for COVID-19 research. “We have one research hotline team that is screening for protocols across the HMH network,” says Cheryl Fittizzi, Vice President of Research and Regulatory Affairs. “We set up an Epic screening tool within the electronic medical record that helps treating physicians or clinical teams to refer patients to clinical trials.”
This was particularly important in the context of COVID because so many families were aware of clinical trials as an option for their sick loved ones and desperate to get them care. “We’ve seen a really high volume of patients’ families tracking us down by name with personal phone calls, emails, and so on,” shares Fittizzi. “It’s not something that our research department generally experiences. To hear the actual patient or patient’s family asking for medication, very desperate because of the condition that their loved one is in — you want to do what you can to help them.” Having a centralized hotline and operations provided a way for the research administration team to ensure treatment got to as many patients as possible with all appropriate protocols followed and without overwhelming their staff.
They also used a command center approach to manage team resources. Employees across the hospital network wanted to contribute to the efforts of the research teams. There were a number of full-time employees who could not work remotely that the research team was able to cross-train to support clinical trials. “There were nurses that had never worked on a trial before and we got them up and running quickly with human subjects training,” shares Avery Freed, Director of the Human Research Protection Program. “Additionally, we had investigators who were COVID-facing clinicians who were not researchers and never done clinical trials. We got them up and running really fast as well.” This centralized and focused approached allowed them to identify, train, and redeploy resources quickly, without compromising safety.
The team also implemented a daily email update for the institution, keeping everyone in a loop about the research being launched across the hospital network. This information channel shared vital information about clinical trials being run across HMH, but also shared inspiring stories with the team during an incredibly difficult time. “It’s brighter every day as we see patients discharged,” says Sean Fitzgerald, Manager of Biological Safety. “Any time there’s a wonderful clinical outcome or people are persevering and overcoming, it’s pretty impressive to hear about. It keeps us all going.”
Leveraging Existing Programs
In addition to new processes, the team saw an opportunity to leverage existing programs to help with COVID research, particularly their biorepository. The biorepository had previously been used to support primarily oncology research, but within days was able to pivot to support COVID specimen collection, since the infrastructure was already in place.
“The only issue was that, rather than collecting 20 or 30 samples a day that’s very targeted for cancer patients, now we had hundreds and hundreds of specimens coming through,” says Dr. Kar Chow, Director of the Hackensack Meridan Health Biorepository. “We had to very quickly expand tenfold in terms of the number of specimens that we were processing every day.”
With how important and time-sensitive the COVID research being conducted was, the biorepository couldn’t afford to have a backlog. The team needed help to process the samples safely and rapidly. Other researchers were quick to volunteer their time to help process the specimens. “These are very senior, well-known researchers that are coming in and they’re saying, ‘I’m going to step up and I’m going to help, because we really need to support this specimen collection,’” says Dr. Chow. “So they’ve made their valuable time available to come in and help, which was very refreshing. It was just really good to know that these researchers value this effort, not only for their own research, but for research as a whole.”
Sharing Learnings with Others
With the initial wave passing, the team is thinking about how to share what they’ve learned. The team created a presentation to share their COVID-19 response across the HMH network, documenting successes and lessons learned. They are hoping to create more documentation and training available to prepare the entire network for future waves of the pandemic.
They are also hoping to encourage a culture of collaboration during the months ahead as the institution continues to balance COVID and non-COVID research. They see the opportunity to bring more clinicians into research. “A lot of people are now more interested in research than they were before,” says Dr. Elli Gourna Paleoudis, Manager of the Investigator Initiated Research Program. “People are learning a lot through this process. People that have never submitted to the IRB before, that have never written a protocol or proposal are now more involved. And it was great for me to see people being interested and an opportunity for our network to get more involved in such important research.”
They also see it as an opportunity increase research collaboration across their organization and between organizations. “I think people now realize that we have to be collaborative,” says Dr. Chow. “We need to make sure that we’re not just thinking about own research, because the data that we’re generating maybe may give us additional insight if we pair it with data that somebody else has.”
In addition, the team encourages institutions to talk with each other to get through this challenging period of unknowns and ambiguity. “Don’t be afraid of reaching out to your contacts,” says Garcia. “Their experience is indispensable.”
“Even if we do get a vaccine or a very good therapeutic that suddenly arises, that doesn’t mean research is going to suddenly end,” says Fitzgerald. “There’s a lot of things that we can learn from this virus that could further elucidate how we fight these pandemics when and if they arise in the future.”
Leadership is Long Term
Above all the team recognizes that this is just the beginning of what is likely to be a priority for years to come. As they look to the future they’re identifying how they continue to support research and their team in the long term. The steering committee is continuing to review research project proposals on a monthly basis. The committee is also reviewing the flood of new industry trials coming out to identify the right balance of projects for their resources and research portfolio moving forward. This will allow HMH to continue conducting important COVID research while ramping back up non-COVID research.
The team is also making sure not to lose sight of the toll the long hours and emotionally draining work is taking on their team and will continue to take in the months to come. “You have to ensure that you protect your team members. That’s critical.” says Dr. Sawczuk.
“There’s personal stress that people are going to have to come down off of,” shares Susan Adler, Director of Clinical Research Operations. “As a leader, you have to think about, how do I support that? How do I make sure my staff is able and ready to come back to work?” The work from researchers and health care workers around the globe during this pandemic has been nothing short of heroic. But as we ask so much of them during this time, we also must be mindful of what we will need to do to support them moving forward.
I’m honored that the team at HMH allowed me to share some of their insights with you (there was much more I couldn’t squeeze into the article). 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 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.