Demonstrating the power of independent community oncology research, ASCO’s Journal of Clinical Informatics has published Operational Metrics for the ELAINE 2 Study Combining a Traditional Approach with a Just-in-TIME model. For Patients enrolled in phase 2 study of lasofoxifene combined with abemaciclib in patients with advanced or metastatic estrogen receptor–positive/ human epidermal growth factor receptor 2–negative breast cancer with an ESR1 mutation, compared to traditional trials the independent community oncology practices
Duration for full clinical trial agreement execution for Traditional sites and TIME Trial sites averaged 200.5 vs. 7.6 days respectively. Institutional review board approval time for Traditional sites and TIME Trial sites was 27.5 vs. 3.0 days respectively. Duration from study activation to first consent was 33.3 vs. 8.8 days for Traditional and TIME Trial sites, respectively. The first patient on study was at a TIME Trial site 115 days before a Traditional site and the first seven patients enrolled were at TIME Trial sites.