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, Carelon Research (formerly HealthCore) has been a key data partner and collaborating institution.
From 2009 to 2014, Carelon Research 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, Carelon Research, among other organizations, was able to help determine what data, methods, and operations the larger Sentinel Initiative would require.
Carelon Research 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 Carelon Research's contributions to the Sentinel Initiative over the years:
- During a recent flu season, about 155 million Americans were vaccinated against the flu. During that time, Carelon Research participated in Sentinel’s inactivated influenza Rapid Surveillance project to monitor four post-vaccination safety events: anaphylaxis, Guillain-Barré syndrome, Bell’s palsy, and infant febrile seizures. Our monthly refreshed data were aggregated with two other Sentinel data partners. Between October 2017 and May 2018, more than 10 million vaccinations were tracked, and no safety events were associated with the flu vaccine.
- We have run hundreds of queries originating from the FDA, and we have focused on improving the national distributed network to answer questions with increased accuracy and timeliness. This experience led us to develop our own queries that can run against the Sentinel common data model (SCDM) in our data and in any other data source following the SCDM specifications.
- As of 2021, Sentinel data partners hold data for over 350 million lives with Carelon Research/Elevance Health (formerly Anthem) managing 21% of them. Carelon Research is currently the only data partner to also offer limited multistate Medicaid data as a separate data source. We have updated our data according to the SCDM specifications over 32 times in the commercial health plan population and three times in the state-approved Medicaid populations.
- With our ability to tie claims back to members, we have been major participants in medical record review studies to validate health outcomes (for example, Kawasaki disease, serious infections, acute kidney injury) identified in claims data. The traditional medical chart reviews reinforce the methods used to answer FDA concerns about associations with these health outcomes.
Because of the Sentinel program, several vaccines and medications (for example, 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 (for example, brand or 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 12 years, the Sentinel Initiative has been an important part of our academic and government work. Though currently situated in the Safety and Epidemiology Research team at Carelon Research, this program is supported across Carelon Research. Key members of the Carelon Research Sentinel team come from the Data Processing and Solutions team, the Data Coordinating Center, and Research Operations. The collaborative nature of the Carelon Research 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.