What if the data behind your next prescription could help save lives – not just yours, but millions more?
Behind the scenes, researchers are turning everyday health records into powerful insights that shape the safety of drugs and medical devices. At the heart of this work is Cheryl Walraven, a health care researcher whose career has bridged mental health, equity and cutting-edge safety surveillance programs. Her story offers a closer look at how real-world evidence (RWE) is quietly transforming the way we protect patients and improve care across the country.
Quality and outcomes
Walraven began her career by identifying treatment options for patients with mental illness and helping veterans find housing and treatment for addiction. This initial foray into the cross-section of mental health and physical health laid the groundwork for her to transition into more comprehensive health care roles which focused on quality and safety.
She spent a significant amount of time with the Joint Commission, conducting quantitative research to benchmark health care organizations in their quality improvement efforts. The work to enhance the accreditation process, included the development of measures to evaluate various hospital departments and processes, ensuring that healthcare delivery organizations across the US, had access to the health-world-data comparisons to evaluate their improvement goals.
Her growing expertise around quality and outcomes landed her a role at a large major health insurer, where she began researching health care quality and disparities amongst different racial and ethnic groups. Over time, this evolved into a broader emphasis on equity and social drivers of health.
The FDA Sentinel Initiative
In 2007, Congress mandated the FDA to actively monitor public health and serious adverse reactions to drugs, biologics (vaccines), and medical devices using health insurance data. Because of Walraven’s experience with data, equity and outcomes, her employer selected her to lead the health plan research team in its participation as a data partner in the FDA Sentinel Initiative, a federal program aimed at enhancing drug, biologic, and medical device safety surveillance. Walraven was tasked with using SAS to transform claims data into a standardized format, or common data model, required by the Sentinel Initiative and performing essential research to ensure that drugs, biologics and medical devices are safe for health care consumers.
Today, the Sentinel Initiative, coordinated by the Harvard Pilgrim Healthcare Institute (HPHCI), collaborates with 20+ Sentinel data partners. The partners are either health plans or integrated health delivery systems that voluntarily participate in this national effort. Each data partner transforms their data using SAS in accordance with the Sentinel common data model requirements. The data set (which excludes any personal or health identifiers) is used by the data partner to summarize safety results and provide aggregate data to the coordinating center, which combines the summarized analyses and reports pertinent findings to the FDA.
Importance of RWE for safety surveillance
The importance of real-world evidence in health care cannot be overstated.
Through rigorous protocols and a commitment to improving patient outcomes, researchers like Walraven make a lasting impact on the field of health care, demonstrating the power that real-world evidence can provide to improve public safety.
Over the years, she and many other researchers across the country have participated in numerous safety surveillance studies, providing the FDA with critical data to monitor safety. This included the rigorous research of various vaccines, including COVID-19, Influenza, RSV and measles. These vaccines are top of mind right now, as we navigate through high levels of acute respiratory illness, which in some cases can be life-threatening and are having a significant impact on our health delivery systems.
The promise of AI
By using AI, researchers and regulators can accelerate and enhance the safety monitoring of drugs, biologics, and medical devices, leading to improved patient outcomes and more efficient health care systems.
According to Walraven, “AI can enhance safety surveillance and collaborative research, as data from numerous sources beyond claims can be incorporated and managed for a more comprehensive analysis. It has been an honor to participate in work that has had such an enormous impact. I am looking forward to supporting ongoing efforts using the advanced tools such as distributed research networks and AI.”
Today, Walraven continues her work as a consultant through her firm, Glade Oak Inc., advising organizations on how to transform their data infrastructure for collaborative research and regulatory compliance. Whether she’s helping a health plan become Sentinel-ready or guiding AI governance efforts, her work is still rooted in the same goal: better care for more people through better evidence.
If you are interested in learning more about this work or understanding how you can transform your data for research and surveillance, you can connect directly with Walraven as she continues to contribute to better care and better outcomes.
