Global Consortium Publishes PRO Standards for Cancer Trials and Launches Implementation Toolkit

Overview

• The SISAQOL-IMI consortium, co-led by EORTC and Boehringer Ingelheim, published a methods paper in The Lancet Oncology detailing how its patient-reported outcomes recommendations were developed.
• Alongside the paper, the group released an online toolkit to help researchers, clinicians, regulators, and policy makers apply the standards in oncology trials.
• The toolkit includes plain-language checklists co-produced with patients to support trial design and consistent interpretation of PRO findings, including resources for patient advocates.
• The recommendations stem from a four-year international collaboration involving academic experts, patients, regulators, health technology assessment bodies, and the pharmaceutical industry.
• The publication builds on the final recommendations launched in February 2025, and additional resources and training materials are planned for the SISAQOL-IMI website.