Uniting science and patient voices: SISAQOL-IMI consortium releases PRO standards and tools

Brussels, 25 November 2025 – SISAQOL-IMI (Setting International Standards of Patient-Reported Outcomes and Quality of Life Endpoints in Cancer Clinical Trials – IMI), an international, multidisciplinary consortium co-led by the European Organisation for Research and Treatment of Cancer (EORTC) and Boehringer Ingelheim (BI) and formed under the Innovative Medicines Initiative (IMI), is pleased to announce the publication in The Lancet Oncology of its pivotal paper¹, along with the release of its online materials. The official release of these outputs highlights the culmination of a four-year collaborative project aimed at providing standardised guidelines for designing, analysing, interpreting, and presenting patient-reported outcome (PRO) data in cancer clinical trials.

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“This publication marks a major milestone in harmonising how patient-reported outcomes are used in cancer clinical trials. By providing clear, accessible tools and standards, we aim to ensure that the patient voice is not only heard but meaningfully integrated into clinical research worldwide. Patient involvement has been essential to ensure the recommendations are scientifically robust and aligned with what matters to those affected by cancer”, explained Cecilie Delphin Amdal, MD PhD, Oslo University Hospital, and lead author of the SISAQOL-IMI publication.

Silene ten Seldam, from Myeloma Patients Europe and co-leader of the SISAQOL Work Package 8 on patient engagement, dissemination strategies and educational programmes/ workshops, added: “Having comparable and transparent data that follows guidelines like the SISAQOL-IMI recommendations not only improves the standardisation of patient-reported outcome (PRO) data in cancer trials but also provides patients with robust, comparable, and transparent data that allows patients to be more involved in their treatment and care decision making”.

Alongside the SISAQOL-IMI publication, which explains how the recommendations were developed, the SISAQOL-IMI website offers practical tools to help users easily find and apply the recommendations that best suit their needs. For example, the online interactive table allows stakeholders to identify relevant recommendations based on the type of trial (randomised-controlled trial [RCT] vs. single-arm trial [SAT]), the objective of the trial (confirmatory vs. descriptive), and the type of PRO endpoint (e.g., responder analysis vs. time-to-event analysis). The online interactive glossary provides scientific and plain language definitions of key terminology, to facilitate understanding across diverse audiences. Finally, an interactive guidebook provides guidance on how to navigate both online tools, while also providing additional information on the goals and methodology of SISAQOL-IMI.

Vivek Pawar, PhD, from EMD Serono and co-lead of the SISAQOL Work Package 7 on the development of international recommendations, emphasised that: “SISAQOL-IMI exemplifies how collaboration between industry, academia, regulatory and HTA bodies, and patient advocates can drive innovation. These tools will help ensure that PRO data is collected and interpreted consistently, ultimately improving decision-making and patient care”.

Plain language materials are also available on the SISAQOL-IMI website, with the goal of ensuring that the patient voice is incorporated into the design, analysis and reporting of PRO data. The plain language materials include three checklists that patients and other stakeholders can use when reviewing clinical trial protocols and visualisations of PRO data, to ensure that these types of documents are in line with the SISAQOL-IMI recommendations.

The SISAQOL-IMI publication was published on 24 November 2025 in The Lancet Oncology and can be accessed here. The SISAQOL-IMI online materials can be accessed on our website here.

In 2026 and 2027, the consortium will continue its work by developing supporting tools and training materials to accompany the recommendations.

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.