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New-Onset Cancer Cases in FDA’s Sentinel System: A Large Distributed System of US Electronic Healthcare Data

    Basic Details

    Evaluations of cancer etiology and safety and effectiveness of cancer treatments are predicated on large numbers of patients with sufficient baseline and follow-up data. To assess feasibility of FDA’s Sentinel System’s electronic healthcare data for surveillance of malignancy onset and examination of product safety, this study examined patterns of enrollment surrounding new-onset cancers. Using a retrospective cohort of patients based on administrative claims, we identified incident events of 19 cancers among 292.5 million health plan members from January 2000 through February 2020 using International Classification of Diseases (ICD) diagnosis codes. Annual incident cases were stratified by sex, age, medical and drug coverage, and insurer type. Descriptive statistics were calculated for observable time prior to and following diagnosis.


    Nicole R. Haug, Anita K. Wagner, Katherine A. McGlynn, Charles E. Leonard, Michael D. Nguyen, Jacqueline M. Major

    Corresponding Author

    Jacqueline M. Major; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, FDA, Silver Spring, Maryland, USA