A MITRE-led collaborative established a system to accelerate verification of COVID-19 treatments—but it brings far broader potential to improve patient outcomes. Our cloud-based repository enables rapid collection and storage of real-world clinical data to inform public health practice and policy.
Data Breakthrough: Preparing for the Next “Unimaginable” Public Health Emergency
“Just think how much more responsive we could be for the next public health emergency than last time,” says MITRE’s Nalini Ambrose, an expert in clinical data quality.
Ambrose imagines a scenario where, in the next pandemic, the U.S. is much better positioned to successfully treat patients—and save lives.
It’s a scenario that hinges on the ability to rapidly translate real-world evidence into practice, based on a host of critical questions: Are treatments working? For whom? Under what conditions?
These questions pervaded the health community in fall of 2021, as COVID raged around the world. The U.S. Department of Health and Human Services (HHS) charged MITRE, operator of the federally funded R&D center for health, to lead a collaborative effort to get the answers.
In just a few short months, our research team, with Ambrose as co-principal investigator, created a public-private collaborative to establish the governance and infrastructure for a cloud-based repository for clinical data.
The initiative aimed to accelerate use of effective COVID-19 therapeutics and improve patient outcomes. The consortium accomplished that—and more.
Just think how much more responsive we could be for the next public health emergency than last time.
A Dynamic System for an Evolving Public Health Problem
The secure data registry the consortium developed enabled a real-world evidence study of the effectiveness of nMAbs, or neutralizing monoclonal antibodies, in treating COVID.
The study drew on MITRE’s expertise in areas such as systems engineering, data analysis, epidemiology, and genomics, as well as our role as a connector of stakeholders across government, industry, and academia.
“Together, we built a massive system to establish the pipeline to take in not only clinical data but also genomic data from many disparate systems,” Ambrose says. “It was a huge lift—and a true team effort, both internally and with our external partners.”
Those partners included four health systems representing various clinical settings: Mayo Clinic, Houston Methodist Hospital, University of California Irvine Health, and Intermountain Healthcare. Along with numerous vendors and consultants, including experts affiliated with Harvard Medical School and from the Duke-Margolis Center for Health Policy, the consortium quickly generated real-world data to produce rich insights that:
- Independently verified Food and Drug Administration’s decisions to issue emergency use authorization for nMAbs, finding them safe and effective in treating COVID-19
- Highlighted the importance of optimizing patient selection for nMAb treatments based on patient risks and helped inform clinical practice at participating health system sites
- Confirmed the benefits of vaccination and boosting in reducing disease severity for some outcomes
Providing Quick and “Clean” Real-World Data to Inform Decisions
What makes real-world evidence so critical during public health emergencies?
To answer that question, we can look back to the early days of COVID. As the pandemic progressed, health officials had to determine the effectiveness of treatments solely based on early and limited clinical trials.
What officials really needed? Access to actionable, real-time, large-scale patient data, particularly as new variants arose.
The MITRE-led consortium collected clinical data on 167,000+ patients diagnosed with COVID-19. It also collected substantial viral genomic data to explore the relationship between SARS-CoV-2 viral variants and clinical outcomes.
Not only did the collaborative move fast to collect the data, but they also initiated a robust process to ensure its confidentiality and quality. This meant removing all protected health information—scrubbing every bit of identifying information (of patients, doctors, healthcare providers, etc.) from the huge data set—no small feat.
“We demonstrated the value of real-world data’s augmentation of clinical trial data to enable clinicians to manage therapeutic approaches during health crises,” says MITRE’s Kim Warren, vice president and director of the CMS Alliance to Modernize Healthcare (Health FFRDC).
Prioritizing Equity in the Search for Answers
The consortium also incorporated health equity into its work, particularly for vulnerable populations. The research team analyzed clinical data with social determinants of health data, such as race, ethnicity, and insurance status. The analysis identified some potential disparities in the use of nMAbs among underserved communities, despite healthcare systems’ best efforts to increase usage.
To broaden the study’s impact, the collaborative committed to making the repository open and repurposeable. MITRE’s GitHub site enables free use of the underlying algorithms and data from this publicly funded work—work that’s informing other important studies around COVID therapeutics.
Beyond COVID, this effort can provide foundations for addressing other healthcare problems.
“Real-world evidence studies can also be used in regular clinical practice and potentially for improving treatment of other diseases, like cancer and Alzheimer's,” Ambrose explains.
The MITRE team will share the consortium’s findings in several journals, as well as at the 2023 Healthcare Information and Management Systems Society conference.
“We’ve demonstrated how nimble we can be as a scientific community,” Ambrose says. “It makes you imagine a different future where this could be in place to help us move even faster.”
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