Research spotlight: improving the surveillance of medical product safety with the real-world evidence data enterprise

How would you summarize your study for a lay audience? 

The Sentinel System is a major component of U.S. Food and Drug Administration’s (FDA) active medical product safety surveillance across the nation. In 2019, the FDA tasked researchers from the Innovation Center, a consortium of researchers led by Brigham and Women’s Hospital investigators, to create a new data infrastructure by leveraging electronic health records (EHRs), which contains detailed clinical information. The goal of this request was to address gaps in the capabilities of the Sentinel system that has historically relied largely on insurance claims data.

Five years later, this work is now complete with the unveiling of the Real-World Evidence Data Enterprise (RWE-DE). The RWE-DE combines longitudinal EHRs with insurance claims data for over 25 million patients across six sites. 

What knowledge gaps does your study help to fill? 

RWE-DE is a major step forward for the Sentinel system that will offer opportunities to improve the validity of studies of medical products in clinical practice and to expand the range of questions that can be answered. Curation and systematic organization of free-text clinical data in RWE-DE will further allow efficient use of this novel type of data in large volumes, which was previously not possible in the Sentinel system.   

How did you conduct your study? 

The effort involved collaboration with academic investigators from Harvard Pilgrim Health Care Institute, Duke University Medical Center, Vanderbilt University Medical Center, Kaiser Permanente Washington Health Research Institute; commercial data aggregators HealthVerity and TriNetX; and the FDA. After four years of selecting appropriate data sources and organizing data in a common data model, the newly unveiled RWE-DE contains harmonized data from the six sites and is ready for analyses whenever the FDA needs it.   

What are the implications? 

The RWE-DE is going to be leveraged by the FDA to conduct studies of medication safety using granular clinical information available in EHRs to identify study populations and to define exposures, endpoints, or confounding variables. These studies will allow the FDA to address emerging needs for safety evaluation of approved medications.   

What are the next steps? 

We are continuing to work towards developing new analytic tools to leverage novel types of data sources available in RWE-DE, such as free-text notes. Thoroughly tested methods, tools and algorithms built within the RWE-DE will ensure timely and efficient execution of drug safety studies with expedited turnaround times to help the FDA monitor post marketing safety of medical products.  

Authorship: In addition to Desai, BWH authors include Haritha S. Pillai, Joyce Lii, Kerry Ngan and Sebastian Schneeweiss. 

Disclosures: This work was supported by funds from the U.S. Food and Drug Administration (FDA) (Master Agreement 75F40119D10037). 

Paper cited: Desai RJ et al. “The FDA Sentinel Real World Evidence Data Enterprise (RWE-DE).” Pharmacoepidemiology and Drug Safety DOI: 10.1002/pds.70028