In this work, we identified ways to calculate real-world endpoints with structured electronic health record (EHR) data, and validated these endpoints against the gold-standard measurements derived from linked EHR and tumor registry (TR) data.
We used the linked EHR and TR data from the OneFlorida network. The OneFlorida network contains linked robust longitudinal patient-level RWD of ~15 million (>60%) Floridians, including data from Medicaid claims, TR, vital statistics, and EHRs from its clinical partners.
We focused on two real-world endpoints: real-world Overall Survival (rwOS) and real-world Time-to-next-treatment (rwTTNT) on early stage (stage I-III) colon cancer patients. The rwOS measures the duration from the date of cancer diagnosis or treatment initiation (depending on the cancer types or study aims) to the date of death or end of follow-up (or last contact); while rwTTNT measures the duration from the initiation of the first course of cancer-directed treatment to the initiation of the next line of therapy (i.e. “subsequent treatment” in the case of recurrence or progression). Although rwTTNT derived from RWD sources have not been examined extensively, it can provide critical insights on real-world performance of cancer treatments. For example, the rwTTNT can be used as a surrogate to estimate progression free survival and the effectiveness of cancer treatment5.