ESMO ORAL SESSION: Applying CSO cheklist for Phase III trials supporing EMA Lung Cancer approvals, 2020-2025
For those of you attending ESMO Madrid, in addition to the CSO symposium , Javier Benítez, from the Rio group is giving an oral presentation on Saturday the 24th. It covers work we’ve done applying the CSO checklist to EMA approvals for lung cancer between 2020 and 2025. we are currently preparing the full paper. Here is the abstract: Background: Common Sense Oncology (CSO) prioritises meaningful endpoints, appropriate comparators, patient-centred outcomes, toxicity burden, and transparent reporting. We assessed adherence to a full CSO-derived checklist in trials supporting recent European Medicines Agency (EMA) lung cancer approvals. Methods: We performed a retrospective review of EMA lung cancer phase III approval-relevant trial-indications from 1 January 2020 to 31 December 2025. After regulatory-date and pivotal-evidence verification, 31 trial-indications were included in a single-review working analysis. Seventy checklist elements were scored separately: 25 proto...
