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The COVID-19 pandemic exposed significant gaps in the healthcare system, such as healthcare inequities and the need for more treatment options for intensive care unit patients with serious illnesses. Looking beyond COVID-19 to sepsis and other critical care illnesses, the Society of Critical Care Medicine and Critical Path Institute’s CURE Drug Repurposing Collaboratory are collaborating on the new study Repurposing Drugs in Intensive Care Units Through Real-World Data Analysis (REDISCOVER-ICU).
The COVID-19 pandemic exposed significant gaps in the healthcare system, such as healthcare inequities and the need for more treatment options for intensive care unit (ICU) patients with serious illnesses. The Society of Critical Care Medicine’s (SCCM) Discovery, the Critical Care Research Network, created the Viral Infection and Respiratory Illness Universal Study (VIRUS) to address some of these gaps through its registry. To accomplish this, data had to be pulled manually from electronic health records (EHRs). Because different systems use different terms for variables, data quality was lacking and the methods were not validated.
The VIRUS registry revealed the need to collect data in a novel way to help reduce the resource burden and improve data collection efficiency for clinical studies. The next step began when SCCM collaborated with Critical Path Institute’s CURE Drug Repurposing Collaboratory (CDRC) on the study CURE ID: Aggregating and Analyzing COVID-19 Treatments From EHRs and Registries Globally, with the goal of crowdsourcing the global medical community for their experience in using repurposed drugs to treat infectious diseases that have no adequate approved therapies, such as COVID-19. CDRC is a public-private partnership with the U.S. Food and Drug Administration (FDA) and the National Center for Advancing Translational Sciences at the National Institutes of Health.
Looking beyond COVID-19 to sepsis and other critical care illnesses, SCCM and CDRC are collaborating on the study Repurposing Drugs in Intensive Care Units Through Real-World Data Analysis (REDISCOVER-ICU), which will use data from EHRs and global registries to aggregate and analyze existing drugs that could be repurposed for critical care illnesses, such as sepsis or acute kidney injury. This study will create a valuable infrastructure for collecting real-world data on critical care drug repurposing with the hope of leveraging this infrastructure beyond COVID-19.
REDISCOVER-ICU extends the work of VIRUS and CURE ID beyond their current scope and tries to address their limitations. By analyzing data from a network of small community health centers to large academic institutions, the study ensures adequate representation of all patients, including minorities and those who live in socioeconomically disadvantaged areas.
A New Way to Collect Data
REDISCOVER-ICU enables the near-real-time collection of data streams clinicians can use when caring for patients. The goal is to build a large, sustainable network that can easily share data to encourage the study of potential treatments.
“Instead of the wild, wild west of gathering data, we’ve focused on building something together,” said Smith F. Heavner, PhD, RN, REDISCOVER-ICU principal investigator, CDRC senior scientific director, and assistant professor of public health and implementation science at Clemson University in Clemson, South Carolina, USA. “Rather than waiting for research coordinators at eight different institutions to manually enter thousands of cases, we're pulling all of those data out in a matter of minutes. Ultimately, that means, instead of spending years trying to study and determine, say, which dose of dexamethasone is best and when to start it, we could shorten that timeline to a couple of months and be much better prepared to identify treatments for the next emerging disease.”
A New Way to Assess Drugs for Repurposing
The concept of repurposing drugs is not new. Critical care clinicians frequently prescribe medications off-label, such as vasopressors to raise blood pressure or steroids for pneumonia or acute respiratory distress syndrome (ARDS). The evidence to support off-label drug use evolves rapidly, and it is essential to capture how clinicians are adapting their practice in response. REDISCOVER-ICU aims to rigorously capture that evidence, studying drugs approved for specific indications that could be repurposed to address other unmet treatment needs. The FDA is particularly interested in treatments for which traditional mechanisms do not incentivize drug development, such as for emerging or rare diseases.
“REDISCOVER-ICU helps develop hypotheses that can be tested in interventional studies,” said Laura E. Evans, MD, MSc, FCCM, REDISCOVER-ICU co-investigator and director of critical care at the University of Washington Medical Center in Seattle, Washington, USA. “REDISCOVER-ICU will further demonstrate the importance of automated data in critical care.”
REDISCOVER-ICU enables the study of complex critical care conditions including sepsis, ARDS, meningitis, and acute kidney injury. It also promises to have broader implications beyond critical care. For example, repurposed drugs may be key to treating long COVID (post-acute sequelae of COVID-19), post-ICU syndromes and ICU delirium, and endemic diseases such as influenza. REDISCOVER-ICU will likely have a massive beneficial impact across almost every aspect of clinical research.
Opening Research Opportunities to Diverse Institutions
VIRUS, CURE ID, and its extension beyond COVID-19 through REDISCOVER-ICU involves analyzing data from a network of more than 30 sites. All are currently U.S. sites. Investigators are continuing to recruit new sites and are in communication with international institutions that have expressed an interest in participating in REDISCOVER-ICU.
“Most healthcare in the United States is not delivered in big institutions,” said Jonathan E. Sevransky, MD, MHS, FCCM, REDISCOVER-ICU co-investigator and professor of medicine and associate division director for critical care at Emory Healthcare Center in Atlanta, Georgia, USA. “REDISCOVER-ICU will help ensure that treatments work for the majority of patients, not just a subset of those who were studied at academic centers.”
Four studies are planned, beginning with long COVID in outpatients and sepsis in inpatients. SCCM will lead the analysis and host the REDISCOVER-ICU portal. All participating sites will have access to the data, and eventually nonparticipating sites will be able to access the data and perform their own ancillary analyses. REDISCOVER-ICU also creates the potential for future AI-focused research to assess the massive quantities of data, numbers of patients, and significant granularity.
“One of the things we realized during the pandemic was the old way of learning how to take better care of patients that’s done at a slow pace over a long period of time doesn’t work for the 21st century, if it ever worked well,” Dr. Sevransky said. “REDISCOVER-ICU allows us to leverage some of the data present in the EHR to allow us to make better decisions in a shorter period of time about how patients respond to medicine. It opens up a new window in critical care research so that we can move quickly to translate it into improving patient care.”
Posted: 9/19/2023 | 0 comments
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