video: The SISAQOL-IMI consortium, co-led by the European Organisation for Research and Treatment of Cancer (EORTC) and Boehringer Ingelheim (BI), just published 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. In this video interview, Dr Madeline Pe, Head of the EORTC Quality of Life Department and co-leader of the SISAQOL-IMI Management and coordination Work Package, tells us more about SISAQOL-IMI, how it came together and its outcomes. More information: https://www.eortc.org/blog/2025/11/25/sisaqol-imi-consortium-publishes-key-paper-and-launches-online-materials/
Credit: European Organisation for Research and Treatment of Cancer (EORTC)
Brussels, 25 November 2025 – 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 paper1 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 standardisation matters
“This publication represents a major step forward in how we capture and use patient perspectives in cancer trials. Standardisation means that data will be more reliable, comparable, and ultimately more impactful in informing patient care and policy,” said 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.
* Learn more about SISAQOL-IMI and explore the online materials here.
1 Cecilie D Amdal, Ragnhild S Falk, Ahu Alanya, Michael Schlichting, Satrajit Roychoudhury, Vishal Bhatnagar, et al., SISAQOL-IMI consensus-based guidelines to design, analyse, interpret, and present patient-reported outcomes in cancer clinical trials, The Lancet Oncology, Volume 26, Issue 12, 2025, Pages e683-e693, ISSN 1470-2045, https://doi.org/10.1016/S1470-2045(25)00520-0.
Journal
The Lancet Oncology
Method of Research
Survey
Subject of Research
People
Article Title
SISAQOL-IMI consensus-based guidelines to design, analyse, interpret, and present patient-reported outcomes in cancer clinical trials
Article Publication Date
24-Nov-2025
COI Statement
KB, JMG, BH, and GR received funding paid to their institution from the Setting International Standards in Analysing Patient-Reported Outcomes and Quality of Life Endpoints in Cancer Clinical Trials-Innovative Medicines Initiative (SISAQOL-IMI) grant to conduct this work. ABe, CQ, NC, and MF received travel grants from SISAQOL-IMI to participate in the annual meeting. EB received consulting fees as a scientific advisor for AZ, Navigating Cancer, Verily, N-Power Medicine, Savor, Thyme Care, and Resilience Health. AC was an employee of Genentech from 2011 to 2019 and then AZ from 2020 to 2024; however, the current work was done as part of PRE LLC and on external time. AC has a patent unrelated to this work (AZ ownership); and reports stocks, leadership roles, receipt of equipment and other services, and other financial and non-financial interest from AZ. PC, JC, and SR are employees of Pfizer and receive stocks and have stock options. MJC received grants paid to her institution from the National Institute for Health and Care Research (NIHR) Birmingham Biomedical Research Centre, Health Data Research UK, Innovate UK, Macmillan Cancer Support, GSK, Research England, European Commission and the European Federation of Pharmaceutical Industries and Associations, Brain Tumour Charity, Gilead, Janssen, NIHR, UK Research and Innovation, and Merck; revenue from commercial licence of the symptom burden questionnaire–long COVID; consulting fees from Aparito, Boehringer Ingelheim, CIS Oncology, Merck, Genentech, GSK, Pfizer, Vertex Pharmaceuticals, ICON, Halfloop, the University of Michigan, Northwestern University, EuroQoL, Shionogi, and Cell and Gene Therapy Catapult; payment or honoraria from the University of Maastricht, Sount-Eastern Norway Regional Health Authority, Cochrane Portugal, and Singapore National Medical Research Council; has a leadership role in PROTEUS Consortium for which she receives a consultancy fee; and her family member has stocks in GSK. OLA received grants and contracts paid to University of Birmingham from NIHR Biomedical Research Centres, NIHR Applied Research Collaborations, NIHR Blood and Transplant Research Unit in Precision Transplant and Cellular Therapeutics, Anthony Nolan Trust, Sarcoma UK, and Merck; and personal consulting fees paid through the University of Birmingham from Merck, GSK, Gilead, Boehringer Ingelheim, and Innovate UK. MB received an unrestricted research grant paid to his institution from Pfizer. KC received travel grants from SISAQOL-IMI to attend the annual meeting; and is an employee for Adelphi Values who consult with pharmaceutical companies. SE had membership fees paid by PRO Consortium member firms to the Critical Path Institute (CPATH) to support staff time to participate in the Consortium; received grants and broad agency announcement contract payments from the US Food and Drug Administration to CPATH; travel funds to participate in the American College of Neuropsychopharmacology 2022 Annual meeting; and travel grants to attend the SISAQOL-IMI meeting. CG is an employee of Bayer and holds stock options. MSc is an employee of Merck and received stocks and stock options. EJP is an employee of AbbVie. JCR is the Chair of the European Organisation for Research and Treatment of Cancer (EORTC) quality of life group (unpaid); is a member of a scientific advisory board for EpilepsieNL (unpaid); and received travel grants to attend the annual SISAQOL-IMI meeting. StS reports that her employer Myeloma Patients Europe receives grant and sponsorship from various pharmaceutical companies, which are listed on their webpage.28 CS received funding from Pfizer and Genentech to her institution; personal consulting fees from Shionogi and Movember; and travel costs from Shionogi to present on a panel at the CPATH COA Consortium meeting. GV received grants from NIHR, Pfizer, and Yorkshire Cancer Research all paid to institution; consulting fees paid from Pfizer, Roche, and Seagen; payments and honoraria from Pfizer, Roche, Novartis, Eisai, and Sanofi; travel support from Pfizer and Roche; payment as part of her participation on a data safety monitoring board or advisory board from Roche, Seagen, and AZ; and holds leadership roles as part of the EORTC board of directors and National Cancer Research Institute Chair of Living with and Beyond Cancer group. All other authors declare no competing interests.