COVID-19: The critical role of real-world evidence made real
In the article below, originally published in HLTH Matters, Carolyn Magill, CEO of Aetion, discusses the opportunity for real-world evidence (RWE) to answer critical questions about treatments and vaccines for COVID-19. This week, Aetion and the U.S. Food and Drug Administration (FDA) took a significant step in realizing this potential when they announced a new research collaboration to use real-world data (RWD) to advance the agency’s understanding of and response to COVID-19.
Read more from Carolyn about the impact RWD and RWE can have on addressing the pandemic below.
Keith, the 63-year-old father of an Aetion colleague, was managing his COVID-19 symptoms for two weeks at home, seemingly successfully. Then he suddenly took a turn for the worse. He was the last patient at his New York hospital to qualify for compassionate use of remdesivir.
My sister’s friend Jim, a healthy 49-year-old, was hospitalized for COVID-19 treatment for over a month. He participated in a randomized trial, and his care included ventilation, extracorporeal membrane oxygenation, hydroxychloroquine, a statin, tocilizumab, and maybe remdesivir.
Max, my colleague’s 15-year-old son, experienced COVID-19 symptoms in the form of a nasty rash on his toes. His doctor advised him to wait and see.
And there are others: my college friend T.J. self-quarantined; my friend’s husband Gavin didn’t realize what he had until after he recovered. The list of people I know who have or have had this virus goes on.
Who’s next? And how on earth will their doctors know which treatment is best for whom—and when? (Also, why is everyone I know who has had a COVID-19 diagnosis male?)
I’m not sure. But I’m certain that it’s critical we look to RWD, right now, for answers.
RWD represent our daily lives as captured by sources like health care claims, EHRs, labs, and wearable devices. These sources provide a rich and current—with as few as two- to three-day lag times—view of patient experiences. Looking at data collected in uncontrolled settings helps shed light on practice patterns and outcomes for people in different demographics and with various comorbidities. Dr. Scott Gottlieb, who’s on our Board, has made a point to say that while these data won’t be the sole basis of assessing and authorizing potential COVID-19 interventions, they are an important adjunct.
With the right level of scientific rigor, we can transform these data into RWE, evidence that is credible enough for conclusions on treatment safety and effectiveness. Moving rapidly but no less rigorously means using Aetion Evidence Platform® to consistently apply principled database epidemiology concepts; to quickly run and rerun analyses as data accrue; and to support transparency and replicability of results.
Naturally, we are not alone in looking to RWD for answers to address the COVID-19 crisis. We’re pleased to join with the Reagan-Udall Foundation for the FDA and Friends of Cancer Research in an effort, COVID-19 Evidence Accelerator, to combine forces (and data) and efficiently resolve key questions about COVID-19. It’s through this kind of cross-industry collaboration with data providers, government, academia, and health systems that we’ll deliver insights to the people who most need them.
For definitive insights without delay, our biopharma and payer partners are also using a COVID-19 specific solution we developed with HealthVerity. The Real-Time Insights and Evidence system enables evidence on treatment utilization and outcomes in a rapidly evolving landscape. Through the integration of data—data that are simultaneously current and complete—into a COVID-ready evidence platform, researchers can create a system of studies to respond in real-time to COVID-19 (and its knock-on effects). All of this will become increasingly helpful as we consider outbreak scenarios in the fall.
I’m grateful to share that Keith, Jim, Max, T.J., and Gavin are all breathing normally again. I’m grateful to all who are helping advance RWE to accelerate safe and effective treatments for many more COVID-19 patients.
Lastly, especially, I’m grateful to the scientists that will lead us to the other side of this crisis, as they help the world understand, manage, and treat disease.