Completeness of Common Data Elements for Breast Cancer Clinical Trials in Observational Databases.

Abstract

Clinical trials serve as a gold standard for data that shapes the healthcare landscape in oncology, but variance in clinical trial eligibility criteria presents challenges for using the data in downstream applications. Identifying common data elements (CDEs) present in cancer trials' eligibility criteria is critical to achieve standardized representations of healthcare data and thus develop trial recruitment tools that generalize to oncology. In this study, we curate a set of CDEs contained in the eligibility criteria of breast cancer clinical trials and evaluate their completeness across different observational databases represented in the Observational Medical Outcomes Partnership (OMOP) Common Data Model. We show that between databases, CDEs are captured with differing levels of completeness across OMOP domains and that there is discordance between the frequency of eligibility criteria CDEs and their completeness in observational databases, which characterizes these databases' utility for subsequent oncology trial matching efforts.