Issues

The cover image is adapted from Figure 1A in the article “New-onset cancer cases in FDA's Sentinel System: a large distributed system of US electronic healthcare data,” by Haug and colleagues. The original image shows the number of total diagnoses and incidence rates per 10,000 person-years by cancer type, among health plan members with medical and drug coverage from all Sentinel data partners. 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 by Haug and colleagues 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. The study found that the FDA Sentinel System's electronic healthcare data may be useful for characterizing relatively short latency cancer risk, examining cancer drug utilization and safety post diagnosis, and conducting surveillance for acute adverse events among patients with cancers. As a national distributed system with electronic health data, the Sentinel system provides opportunity for rapid pharmacoepidemiologic assessments relevant in oncology. For more information, see the article beginning on page 1890.