at the speed of the “pandemic” | Medicine School


At the speed of the “pandemic”

What rapid and emerging processes for clinical trials that the Faculty of Medicine of the University of Montreal will maintain and develop

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After hearing about the first US-based COVID-19 case, for some it probably looked like a few hours later hospitals were struggling to find beds, positive cases quickly increased and everyone took refuge with him indefinitely. Panic of a pandemic set in faster than understanding.

But, doctors and scientists around the world have likely fought their innate desire to fear and worry on a daily basis to focus instead on solutions that would save their patients’ lives. How, however, could medicine and science even begin to match the speed of the pandemic? The process of bringing clinical results from the research bench to the bedside is not known to be hasty. In fact, research shows that, on average, it takes 17 years for research to reach clinical practice.

“It’s a problem, and we had to think creatively last year about how to overcome that to provide real-time care to our patients,” said Brad Benson, MD, professor in the departments of medicine and of Pediatrics at the University of Minnesota. Faculty of Medicine and Director of Studies for M Health Fairview. “Our state’s first and only COVID-19 hospital was the result of this creative thinking and quickly became a place where bedside care teams and leading researchers collaborated directly to find better ways to treat this disease. This process has proven that we can effectively conduct clinical trials, from approval to completion completion, in much shorter time frames than we have seen historically. The lessons learned should change the way we do things in the future.

It shares three themes from the past year that have permanently shortened the time between achieving clinical results and improving patient care between U of M medical school and within the M Health system. Fairview:

Develop a common goal

Communicate systematically

Leverage big data and technology

Develop a common goal

Prior to COVID-19, M Health Fairview adopted the addition of “new cumulative research participants” as the sixth key performance indicator against which leadership would be judged. The team set it 10% higher than the 2019 totals. Then the pandemic started. By the end of 2020, 26 COVID-19 clinical trials alone had shattered expectations for the year, and coupled with nearly 1,000 other clinical trials already underway in the healthcare system, totals for 2020 had reached a record growth of 41% compared to 2019.

“We have such a strong common goal within the research partnership that we have become a health system committed to making research metrics one of our key performance indicators,” said Dr. Benson. “We had a large pool of scientists ready and able to pivot quickly, and we had leaders supporting that in every way. So when COVID-19 hit, we were all already focused – from bedside providers to our research teams – so all the traditional barriers to doing research were gone. ”

Dr Benson has joined a few other leaders within the M Health Fairview system which has become the first stop for all COVID-19 research proposals.

“Because we have a 40,000-foot view of available resources and all the different things that are going on in the organization, this team goes through all the research before it starts,” says Dr. Benson. “We have a special category for COVID-19 research, given that it is so essential to providing information and the best care to our patients, and it is being accelerated. It has removed all barriers and immediately brings resources to support. “

Communicate systematically

covidWith no therapy or known cure, providers around the world initially struggled to understand the best care plan for their patients with COVID-19. Dr Benson remembers his team “being bombarded” with potential treatments, leading to additional stress and confusion in an already busy clinical environment. Thus, his team has developed some methods to systematically communicate on research.

“To help them, we brought in a team that put together evidence-based reviews of what works, what doesn’t and what we as a system would support in terms of treatment. He said. “And, the research that we endorse, we make sure it adds – not an intrusion – to the care of the bedside team. “

To do this, Dr Benson says bedside teams meet directly with the principal investigators of any COVID-19 study with the aim of resolving issues and collaborating on a weekly basis. And, on a daily basis, the leadership team at M Health Fairview addresses any research concerns before 10 a.m.

“Our healthcare system has launched daily caucuses that start at 7 am every day. And, if a problem arises in that caucus that cannot be resolved, it escalates into the next caucus,” says Dr. Benson. “If there is an issue that has seeped into each of the five layers of caucus that has yet to be resolved, then there is a plan for it by 10 a.m., which is being discussed in the caucus. senior management. For anything that could impact care, research or education, this communication is absolutely critical and something that we will continue to use after the pandemic. “

Leverage Big Data and Technology

M Health Fairview led the way in COVID-19 patient care by establishing one of Minnesota’s first – and only one – COVID-19 cohort hospital.

“For this reason, we are able to offer new therapies and potential new care to people in a timely manner, but it has also helped us to develop our own internal database essential to our research,” says Dr Benson. . “We used some of the world-class data scientists at the University of Minnesota who allowed us to ask and answer the questions early on that fueled our research. “

covidResearchers from the M Health Fairview system also worked with UnitedHealth Group of Minnetonka, Minnesota, which had the largest database of COVID-19 patients in the world. This partnership has led to several critical insights into potential COVID-19 treatments, helping to launch a multi-site trial – led by the U of M School of Medicine – that is currently investigating the use of metformin as an outpatient treatment to prevent hospitalization of patients recently infected with SARS-CoV-2.

“We used advanced data science techniques to identify people who were taking certain drugs, found that a good chunk of them may not have been hospitalized, and then looked at that drug,” explains the Dr Benson. “And, some of our clinical trial services are even offered internationally through remote consent with study participants, Zoom, and access to electronic health records. “

These data and other technologies provided additional support to help allocate scarce resources.

“Within our hospital, we have developed a scoring system to determine who is at the lowest and highest risk of serious illness from COVID-19, so that in emergencies it offers clinicians assistance with the immediate decision as soon as the patient’s positive test appears, ”he said. “This gives us an idea of ​​those who may look great at the time of diagnosis but have a high likelihood of getting really sick. We were able to enroll them in a program that contacts them daily to make sure they are not progressing. not and get them in quickly if they get worse. Our patients and families have appreciated that connection. “

Dr Benson points out that institutions capable of adopting a “learning health system” approach – where scientists are integrated into the process of providing care – will thrive in a post-pandemic research world.

“We can’t act as nimbly and quickly as we do because we’re willing to succeed or fail quickly and then learn from it,” he says. “It really allows us to make decisions quickly, resolve any research hurdles, and come together not only for the patient in front of us, but also for a world reeling from COVID-19. We have learned that what motivates us, which is to make the world a better place, one patient, one learner, one discovery at a time, is best achieved when we do it together.

University of Minnesota School of Medicine Launches COVID-19 Vaccine Trial

The clinical trial, which ended in February 2021, tests the safety and efficacy of an investigational vaccine developed by US biotech company Novavax, Inc., called NVX-CoV2373. Novavax is an advanced biotechnology company developing next-generation vaccines for serious infectious diseases.


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