With no end to the COVID-19 pandemic in sight, hospitals and research institutions are grappling with how to run what was business as usual in an environment that’s anything but business as usual. Fiscal pressures are mounting as health care providers suffer massive budget shortfalls and teams are being asked to run critical research and manage significant logistical hurdles with fewer resources. As part of our series on how research leaders are adapting during this unpredictable time, we’re speaking with the research leadership team from Allina Health about how they are conducting research during COVID.
Based in Minneapolis, Minnesota, Allina Health operates 13 hospitals and 90 clinics. The research team for Allina Health has 100 staff members running around 650 IRB-approved studies across the health system. The research program is facing many of the same challenges seen at organizations across the country: new COVID precautions, waves of COVID trials, tightening budgets, and no timeframe for returning to “normal”. They’ve met these challenges with a strong focus on return on investment (ROI) and resource management.
Enact Structure to Evaluate ROI
Before the COVID pandemic hit, Allina Health’s Vice President of Research, Vani Nilakantan, PhD, was already restructuring the research organization to focus on quantifiable metrics to provide better ROI data on their research efforts. “ROI is the big question for all of us in our system, even before COVID,” says Dr. Nilakantan. “About two years ago, there was no good quantification of the ROI such as patient outcomes, scholarship or financial transparency for the research program. We restructured research to streamline operations, have standardized processes and to develop a more financially sustainable path for us. Then COVID added a sense of urgency to what we were already doing. COVID heightened and expedited the process for us to be nimble and agile and have the adaptability and ability to change with the circumstances quickly.”
And that work is paying significant dividends, allowing the team to make quick decisions regarding dozens of trials, both COVID and non-COVID related. To assess a potential study, the team looks at five factors: patient benefit, funding, scholarship (publications and presentations), patient enrollment in clinical trials, and community benefit. By focusing on quantifying these five factors, they’ve created a strong process for assessing research projects, which has served them well during the pandemic.
Streamline Duplicative Processes
The COVID pandemic has also shined a light on duplicative processes in their clinical trial launch workflows. “The research industry is a behemoth,” says Dr. Nilakantan. “There is a lot we know we can do in terms of process improvement. I think that’s where using lean strategies to accelerate process improvement is going to be hugely important. We find that a lot of steps are duplicated by multiple teams. For example, you’ll have a departmental legal team review a contract, and then it has to be reviewed again by a central legal team. It’s an expensive duplication of effort, which could be switched to a single review point.
By identifying these duplicative efforts, the team has been able to speed up trial launch processes, without sacrificing research quality or patient safety. This, combined with allocating resources from other therapeutic areas to assist with COVID research, has allowed their leaner teams to continue delivering on their research portfolio during these challenging months. Soon after the pandemic hit, the system’s research leadership provided guidance for the research teams whereby studies with no immediate clinical or therapeutic benefit were paused. The research department also quickly pivoted to using tele-consenting and tele-monitoring methods, where possible, allowing for critical research in cancer, cardiovascular and other disciplines to continue while ensuring safety of patients and employees.
Don’t Shy Away from Tough Decisions
Being laser-focused on only taking on trials that they can execute on successfully and that deliver solid ROI means making tough choices on what research to pursue. With sponsors approaching Allina Health with dozens of COVID-related trials, the research leadership has had to be strict with their decision making about what trials to take on. They rapidly set up an ad-hoc system-wide committee to review potential COVID trials, not just for the organization’s ability to execute on the trial, but also to vet the clinical significance, scientific merit of the proposed study. This level of scrutiny for industry trials is new, but crucial during a time where our understanding of COVID and how to treat it is evolving so rapidly.
According to Allina Health’s Director of Clinical Informatics and Research Analytics, Vino Raj, MD, the committee has had to carefully vet COVID studies to ensure the organization could deliver on the study, as some COVID studies are particularly resource-intensive. “Every week we have 10 studies come my way,” says Dr. Raj. “We vet those and send them to the Ad-Hoc Committee. Then we look at whether it aligns with the institution, works with our available resources, and assess the return on investment. At the end of the day, we have to do look at those things to make sure we are financially secure.”
In addition to the COVID council, Allina Health has research councils for each therapeutic area. These councils are encouraged to reject research projects that don’t align with the organization and maximize resources. “Each research area has a research council, and we’ve empowered the research councils to say no more readily and easily. They have to be able to say no because there’s only so much teams can do,” says Dr. Nilakantan. “We have a simple two-page template that investigators need to fill out that each council will review and they decide whether it fits in with their priorities or not, and refuse trials that are not really fitting in. Our cancer group, for example, refuses or rejects more than 60% of the studies that come through their door. So, that’s the level of rigor we do need because we don’t want just to have a huge number of studies. We need to have studies of value.”
Identify How Technology Can Help
In addition to cumbersome processes, health systems are also recognizing that they’re suffering from cumbersome technology systems as well. “One of the biggest things that the industry needs to invest in is the integration of technology,” says Dr. Raj. “If you take any other technology any other industry, the technology is there but the integration is there as well. Everything talks with everything. But if you take the healthcare industry that is still very lacking.”
This lack of integrated technology slows down research, but also provides a critical opportunity for organizations to invest and differentiate themselves. By identifying the weaknesses or gaps in their workflows caused by data issues and finding tools that can solve them, they can help their small teams make better use of their time and data.
Build Long Term Relationships with Like-Minded Partners
With no end to these challenges in the foreseeable future, organizations like Allina Health are looking to build partnerships with sponsors and organizations that share their vision for the future of clinical trials.
Allina Health’s Director of Research Operations, Victor Melendez, PhD, is focused on identifying potential partners and then cultivating mutually beneficial relationships over time. “The more I can cultivate those relationships and the more transparent we can be, the more seamless it is for everyone,” says Dr. Melendez.
“These partnerships are going to be extremely important in the future to sustain not just the research program but really the system as a whole,” says Dr. Nilakantan. But as Dr. Raj points out, “it’s a marathon, not a sprint. Sponsors might have to bear understanding that this will take time to put in place the changes we need in the industry. We understand that we cannot do this alone and partnering with purpose with other organizations gives us a combined strength to achieve solid outcomes for our patients and communities.”
From this experience, the team at Allina Health hopes to see increased focus on researching infectious disease. “Infectious diseases have, for at least a couple of decades, taken a backseat because they are generally more easily managed,” says Dr. Melendez. “We may have lowered our guard as a nation to it.”
“The industry goes where the money is and the money has been in cardiovascular, cancer, and what we call the diseases of rich countries, while infectious diseases, such as malaria, are completely ignored. The pandemic has really brought that into the forefront,” says Dr. Nilakantan.
They also hope to see the industry lean into the disruption and build an industry based on flexibility. “It’s about time to embrace disruption. We are constantly fighting that temptation to be insular and exclusive, but I think the time really has come to break that mold,” says Dr. Raj. “Embrace this disruption. Rather than sitting around mourning we can be asking ourselves, how can we embrace this and how can we move forward?”
“The importance of flexibility comes to mind. Sometimes we get into a box with research and say I need it to be exactly this way to do this research.,” says Dr. Melendez. “We need to remain flexible and we need to collaborate to achieve that.”
Thank you to the team at Allina Health for sharing their 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 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.