SISAQOL-IMI provides guidance for implementing patient-reported outcomes in cancer clinical trials

The SISAQOL-IMI consortium, co-led by the European Organisation for Research and Treatment of Cancer (EORTC) and Boehringer Ingelheim (BI), just announced the publication of its pivotal paper in The Lancet Oncology outlining how its recommendations for patient-reported outcomes (PROs) in cancer clinical trials were developed. Alongside the publication, the consortium has released a suite of accessible online materials designed to support researchers, clinicians, regulators, and policy makers in implementing these recommendations.

Why PRO standardization matters

This publication represents a major step forward in how we capture and use patient perspectives in cancer trials. Standardization means that data will be more reliable, comparable, and ultimately more impactful in informing patient care and policy."

Madeline Pe, Head of the EORTC Quality of Life Department and co-leader of the SISAQOL-IMI Management and coordination Work Package

This milestone marks the culmination of a four-year international collaboration uniting academic experts, patient representatives, regulators, health technology assessment bodies, and the pharmaceutical industry. The project's goal: to establish standardised, consensus-based guidelines for designing, analysing, interpreting, and presenting PRO data in oncology clinical trials.

PROs capture the patient's perspective on their symptoms, side effects, and overall quality of life. While widely collected, differences in methodology have historically limited their impact on treatment decisions, regulatory evaluation, and health policy. By providing a harmonised framework, the SISAQOL-IMI recommendations can improve the quality and consistency of PRO data—ensuring patient voices are more effectively integrated into cancer research, drug development, and clinical care.

Inside the SISAQOL-IMI recommendations: A global consensus

This new publication builds on the public launch of the final recommendations in February 2025, offering detailed insight into the rigorous process used to reach consensus, including systematic reviews, stakeholder consultations, and methodological testing.

Anders Ingelgaard, from Boehringer Ingelheim and co-leader of SISAQOL-IMI Management and coordination Work Package highlighted that: "These recommendations are the result of unprecedented collaboration across sectors and disciplines. By bringing together patients, regulators, clinicians, researchers, and industry, we have created a common language for patient-reported outcomes in cancer clinical trials. This will not only improve the scientific robustness of PRO data but also ensure that the patient voice truly informs regulatory and policy decisions worldwide".

New toolkit: Practical resources for implementation

The newly released online toolkit provides practical resources—including guidance documents—to support implementation across the research and policy landscape.

Silene ten Seldam, from Myeloma Patients Europe and co-leader of the SISAQOL Work Package on Patient engagement, dissemination strategies and educational programmes/workshops, explained: "The SISAQOL-IMI plain language checklists [part of the toolkit] offer a co-produced, evidence-informed resource to better support stakeholders, including patient advocates, in the design of clinical trial protocols and promote meaningful and consistent interpretation of cancer PRO findings. Integrating these tools within the broader implementation of the SISAQOL-IMI recommendations will ultimately support meaningful patient involvement in the development of new trials in oncology".

Looking ahead, work will continue, and more resources will be made available on the SISAQOL-IMI website, including training materials. Stay informed by following EORTC and SISAQOL-IMI on social media.