Research conducted under the collaboration will support FDA objectives to explore the natural history of the disease, as well as treatment and diagnostic patterns through the use of relevant and new data sources.
Health tech company Aetion and the U.S. Food and Drug Administration (FDA) signed a collaboration agreement to use real-world data to advance the understanding of and response to COVID-19, the novel coronavirus that continues to sweep across the globe.
Research conducted under the collaboration will support FDA objectives to explore the natural history of the disease, as well as treatment and diagnostic patterns through the use of relevant and new data sources. Aetion and the FDA will analyze the data in order to characterize COVID-19 patient populations and their medication use, identify risk factors for COVID-19-related complications and contribute to the scientific evaluation of potential interventions. The collaboration will use Aetion’s technology platform, known as the Aetion Evidence Platform, which includes structured workflows and transparent reporting to facilitate efficient sharing, examination, and reproduction of findings. Aetion recently updated its platform to include medical and pharmacy claims, lab tests and results, hospital chargemaster data, and relevant EHR fields around COVID-19.
Real world data, also known as real world evidence (RWE), relates to the collection of information about a drug’s safety and efficacy outside the structure of a clinical trial. The data can be collected from a variety of sources, including electronic health records, wearable devices, lab tests and more. The use of RWE has become more important over the past several years and was championed by former FDA Commissioner Scott Gottlieb who is a member of the Aetion board of directors.
Aetion Chief Executive Officer Carolyn Magill said the collaboration with the FDA will employ the company’s analytical technology platform and numerous data sources to develop actionable insights to serve patients and the healthcare industry. With COVID-19 continuing to be the top health concern of the day, Magill said it is critical that the data points gathered by health professionals be analyzed and disseminated in order to produce those actionable insights.
Amy Abernathy, principal deputy commissioner of Food and Drugs at the FDA, echoed that need to harness the abundance of data as the battle against COVID-19 continues. In a statement this morning, Abernathy said the FDA is approaching the plethora of COVID-19-related RWE with a sense of urgency to “learn what we can, as soon as we can, from patients who are receiving care right now.”
“We also recognize that COVID-19 is a dynamic situation. We can use current data and learn what decisions we can confidently make now, and we can learn what we’ll need to do in the future as more data become available,” Abernathy said.
There are nearly 5 million confirmed cases of COVID-19 across the globe, including 1,508,937 in the United States. The disease caused by the virus has taken the lives of 319,031 people, with nearly one-third of those being in the United States. Pharma companies and researchers have been scrambling to develop treatment options and potential vaccines for COVID-19. There are more than 300 ongoing studies of these assets, including more than 100 potential vaccine candidates. With the number of studies out there, the FDA and Aetion said the researchers conducting these programs are facing unique challenges in planning clinical programs. That makes the need for RWE even greater, the company said.
“COVID-19 has delivered an unprecedented shock to the health care system and brings new urgency to how we analyze real-world patient experiences,” Jeremy Rassen, co-founder, president, and chief science officer of Aetion said in a statement. “By conducting real-world evidence studies that apply the highest scientific standards, we can support the FDA as it advances an evidence-based understanding of COVID-19.”
