FDA Analyzing Real-World Evidence on Covid-19

(Gerd Altmann, Pixabay)

19 May 2020. The Food and Drug Administration is analyzing collections of health records to gain more evidence-based insights into the course of the Covid-19 pandemic. The agency’s analysis of real world evidence from a variety of health data sources is conducted with Aetion Inc., a New York-based health analytics and technology company. Financial details of the agreement were not disclosed.

Aetion applies big-data analytics to patients’ electronic health records and other sources to derive answers on safety and effectiveness of treatments for pharmaceutical and biotech companies, health care providers, insurance companies, public health authorities, and regulators including FDA. The company taps into electronic health records, insurance claims, clinical trials, patient registries, wearable devices, and lab results for its raw data, then integrates the widely diverse types of data for analysis by statistical models and other algorithms.

As reported by Science & Enterprise last month, Aetion and another health analytics company, HealthVerity in Philadelphia, joined forces to assess proposed treatments from health records data on patients with Covid-19 infections. HealthVerity offers de-identified data from more than 330 million patients that users can search by diagnosis, treatment, procedure, lab test, or biomarker. The companies say their system tracks use of proposed therapies, as well as outcomes indicating safety and effectiveness, provided along with trends and data visualizations.

In the new project, Aetion and FDA are collecting and evaluating real-world evidence to better understand the Covid-19 patient population, symptoms they express, medications taken, and risk factors for complications. These rapid analytics are expected to help FDA better evaluate proposed diagnostics, vaccines, and treatments as the pandemic continues to spread, and cases, hospitalizations, and deaths increase throughout the country.

“Evaluation of real-world data,” says FDA principal deputy commissioner Amy Abernethy in an agency statement, “has the potential to provide a wealth of rapid, actionable information to better understand disease symptoms, describe and measure immunity, and understand available medical product supplies to help mitigate potential shortages.”

Jeremy Rassen, Aetion’s  president, and chief science officer, adds in a company statement released through Cision, “Covid-19 has delivered an unprecedented shock to the health care system and brings new urgency to how we analyze real-world patient experiences. 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.”

Aetion and FDA are already collaborating in another project known as RCT Duplicate — RCT stands for randomized clinical trials — where insurance claim data are analyzed over longer time periods than typical clinical trials. The RCT Duplicate project aims to analyze these real-world evidence collections as a way to gain systematic and rigorous insights on effects of treatments over time.

More from Science & Enterprise:

• FDA Issues Covid-19 Therapy Trials, Review Guidance
• FDA Outlines Trial Disruption Steps Due to Covid-19
• FDA Issues Draft, Final Gene Therapy Guidance
• Safety Reports Analyzed with A.I. to Reduce Medical Errors
• FDA – New Processes, Incentives Needed for Drug Shortages

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