HealthCore Impact Study: A Sentinel Data Partner and Scientific Collaborator
In celebration of HealthCore’s 25th Anniversary of Founder’s Day, we’re rolling out a series of articles highlighting some of our most impactful work. These ‘impact studies’ have contributed to the growing evidence base that influences healthcare decision makers and healthcare policy and/or practice. They also showcase HealthCore’s diverse service offerings. Though all our work aims to improve the quality of healthcare, we’re especially proud of this work from research teams across our organization.
Is there an association between influenza vaccine and febrile seizures? What is the prevalence and incidence of fingolimod use, an immunosuppressive drug used to treat flare-ups of multiple sclerosis?
The Food and Drug Administration (FDA) is using the Sentinel Initiative, a federally-mandated active surveillance system that uses routine querying tools and pre-existing claims and electronic healthcare data from multiple sources, to answer questions like these as they monitor the safety of post-market regulated medical products, including drugs, biologics, and medical devices.
From the time that the FDA began the Sentinel Initiative in 2008, including the launch of the Mini-Sentinel Pilot Program and the full-scale Sentinel Initiative in 2016, HealthCore has been a key data partner and collaborating institution.
From 2009 to 2014, HealthCore worked together with the Harvard Pilgrim Healthcare Institute—home of the Sentinel Operations Center—on the Mini-Sentinel pilot project, which was the initial phase of the Sentinel Initiative that served as a laboratory to develop and evaluate policies that would be necessary for the full program. The pilot program yielded hundreds of queries annually during its five-year span, and produced studies on a variety of immunizations, biologics, and drugs that have made a significant impact on healthcare. From the Mini-Sentinel program, HealthCore, among other organizations, was able to help determine what data, methods, and operations the larger Sentinel Initiative would require.
HealthCore and other scientific collaborators have continued to refine the capabilities of the Sentinel Initiative while addressing questions about FDA-regulated drugs and products and explored ways to address public health concerns, such as the quality of medical care and biomedical research.
The following are just a few examples of HealthCore’s contributions to the Sentinel Initiative over the years:
Because of the Sentinel program, several vaccines and medications (e.g., rotavirus vaccine, gadolinium-based contrast agents, montelukast) have had labeling changes to reflect possible adverse events and side effects more accurately. On the other hand, potential safety concerns for other medications (e.g., brand/generic sertraline, apixaban, phosphodiesterase type 5 inhibitor use by pregnant women) were not found in Sentinel analyses, resulting in no required updates to labels or patient communications. These outcomes were achieved while maintaining patient privacy and confidentiality because only aggregate or regulatory-compliant, limited, minimum necessary data were shared with the Sentinel Operations Center.
Over the past twelve years, the Sentinel Initiative has been an important part of our academic and government work. Though currently situated in HealthCore’s Safety and Epidemiology team, this program is supported across HealthCore. Key members of the HealthCore Sentinel team come from the Data Processing and Solutions team, the Data Coordinating Center, and Research Operations. The collaborative nature of the HealthCore Sentinel team mimics the nature of the Sentinel Initiative where the whole is greater than simply the sum of its parts.
In 2017, the FDA wrote in its final Sentinel assessment report that “[Sentinel’s] data infrastructure and associated suite of tools and methods are increasingly robust, and the question now is no longer if Sentinel will be used in regulatory decision-making, but rather how best to cost-effectively scale and embed it even further.” Within several FDA centers, leadership is actively promoting the use of Sentinel in cases with regulatory implications where it could reduce cost and time to return comparable or better results than traditional studies. As such, Sentinel is integral to post-market safety and epidemiology analyses.
As experts in answering safety and effectiveness questions and navigating regulatory requirements, we are committed to providing input for and engaging in this collaborative, national (and potentially international) process. From our experience as a Sentinel data partner and scientific collaborator, we have embraced the utility of distributed data networks and common data models, and we are using this knowledge in our other research studies to provide valuable insights into drug safety and effectiveness questions.
For more information about our Safety & Epidemiology capabilities, including Pregnancy Outcome Studies, Single and Multi-Database Post-Authorization Safety Studies, Risk Evaluation and Mitigation (REMS), Validation Studies and Machine Learning, Medical Record Review and Abstraction, and Survey Based Research, visit our Safety & Epidemiology services page.