Sentinel May be Useful in Short Latency Cancer: Study

Former CDER staffer Jacqueline Major and colleagues at Harvard, the University of Pennsylvania, and the National Cancer Institute say the FDA Sentinel System’s electronic healthcare data may be useful for characterizing short latency cancer risk, examining cancer drug utilization and safety post-diagnosis, and conducting surveillance for acute adverse events among patients with cancer. Writing in Cancer Epidemiology, Biomarkers, and Prevention, the researchers say they used the Sentinel data to examine patterns of enrollment surrounding new-onset cancers. They explored 19 different cancer outcomes to understand trends in cancer incidence and describe the availability of longitudinal information surrounding cancer onset, both before and after a cancer diagnosis.

“Our findings suggest that Sentinel is a potentially valuable source of real-world data for drug safety studies in the field of oncology,” the researchers write. “With over 10.5 million new-onset cancer events identified from 2000 to 2020, Sentinel may be useful for characterizing at the population level cancer risk in the post-approval setting, examining cancer drug utilization post diagnosis as well as safety post diagnosis for which drug use would be hypothesized to be a major contributing factor, or acute adverse events. However, utilization of Sentinel may be limited in its ability to examine rare cancers that require larger sample sizes or cancer risks in newly-approved drugs for which there is a limited duration of exposure of the medical product.”