SISAQOL-IMI: Setting standards for the use of patient-reported outcome data in cancer trials

Brussels, 1 June 2023 – Today , the European Organisation for Research and Treatment of Cancer (EORTC) is excited to share the publication of the first consensus paper by the SISAQOL-IMI Consortium1. The paper provides an overview of the stakeholders’ views on the need for SISAQOL-IMI and the agreed priority set of patient-reported outcome (PRO) objectives that the Consortium will produce international consensus-based recommendations on.

The Setting International Standards in Analysing Patient-Reported Outcomes and Quality of Life Endpoints in Cancer Clinical Trials – Innovative Medicines Initiative (SISAQOL-IMI)2 is an international multidisciplinary consortium, co-led by the EORTC and Boehringer Ingelheim (BI) under a public-private partnership funded by the IMI. Building on the initial SISAQOL work3, this Consortium aims to improve the way patient-reported outcomes (PRO) are used in cancer clinical trials by developing a consensus-based set of best practice recommendations for the design, analysis, presentation, and interpretation of PRO data.

PROs are any outcome reported directly by the patient such as a patient’s description of their disease-related symptoms, treatment side effects, functioning and their impact on their health-related quality of life.4 While PROs are playing an increasingly important role in the decision-making by different stakeholders, there is still a lack of standards and guidance on how PRO data are collected and used in cancer clinical trials.

Dr Madeline Pe, Head of the EORTC Quality of Life Department and Lead author of the paper, highlights the importance of this project, pointing out that: “By developing international multi-stakeholder consensus recommendations, we are able to address the challenges faced by various stakeholders in incorporating PROs in cancer clinical trials.Anders Ingelgaard, from Boehringer Ingelheim and co-leader of SISAQOL-IMI Work Package 1, adds that: “Improving standards on how we incorporate PRO data in clinical trials will help ensure that the patients’ voice is included in the evaluation of cancer therapies.


The IMI call on improving standards for PRO analysis recommendations shows how important these standards are in supporting the use of PRO data for optimal drug development and device approval by regulators and HTA bodies, and for the communication between clinicians and patients for the purposes of shared decision making. The SISAQOL-IMI Consortium addresses this need by building on the previous work of SISAQOL and extending its coverage to include single-arm studies and defining clinically meaningful difference.

As design, analysis, presentation, and interpretation of PRO data is a complex and multifaceted issue, this Consortium brings together a broad group of esteemed international experts, coming from academia, industry, non-profit/cancer organisations, small to mid-size enterprises or contract research organisations (CRO), regulators, health technology assessment (HTA) bodies, and patient organisations. The involvement of patients, caregivers and patient representatives is essential to this effort as their contribution will ensure the recommendation statements and their use remain relevant to the patient community.

As Kathy Oliver, from the International Brain Tumour Alliance and WECAN, highlights: “When developing the proposal for SISAQOL-IMI, the Consortium made sure that at least two final recommendation documents will be developed: a technical document aimed at statisticians and similar stakeholders, and a plain-language version tailored for use by the patient, caregiver, and clinical communities. This will ensure the recommendations are understandable and meaningful to stakeholders irrespective of their statistical knowledge and methodological background.


The European Organisation for Research and Treatment of Cancer (EORTC) is a non-governmental, non-profit organisation, which unites clinical cancer research experts, throughout Europe, to define better treatments for cancer patients to prolong survival and improve quality of life. Spanning from translational to large, prospective, multi-centre, phase III clinical trials that evaluate new therapies and treatment strategies as well as patient quality of life, its activities are coordinated from EORTC Headquarters, a unique international clinical research infrastructure, based in Brussels, Belgium.

About the Quality of Life Group

The Quality of Life Group (QLG) strives to improve health-related quality of life (HRQoL) of cancer patients, through dedicated research and the use of HRQoL measures within cancer clinical trials and clinical practice. HRQoL constitutes an important aspect of cancer research and care: it gives a voice to patients, putting their experience at the forefront. The QLG is part of the European Organisation for Research and Treatment of Cancer (EORTC).
For further information, please visit the QLG website.


Caroline Hance (EORTC QLG)
Strategic Lead Communication

1 Pe M, Alanya A, Falk RS, et al. Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints in Cancer Clinical Trials-Innovative Medicines Initiative (SISAQOL-IMI): stakeholder views, objectives, and procedures. Lancet Oncol 2023; 24: e270–83.
2 The SISAQOL-IMI project has received funding from the Innovative Medicines Initiative (IMI) 2 Joint Undertaking under grant agreement No 945052. The IMI Joint Undertaking (JU) is a public-private partnership (PPP) between the European Union (EU), represented by the European Commission (EC), and the European Federation of Pharmaceutical Industries and Associations (EFPIA).
3 Coens, Corneel, Madeline Pe, Amylou C. Dueck, Jeff Sloan, Ethan Basch, Melanie Calvert, Alicyn Campbell et al. “International standards for the analysis of quality-of-life and patient-reported outcome endpoints in cancer randomised controlled trials: recommendations of the SISAQOL Consortium.” The Lancet Oncology 21, no. 2 (2020): e83-e96.
4 European Medicines Agency OWP. European Medicines Agency Reflection Paper on the use of patient reported outcome (PRO) measures in oncology studies [Draft]. 2014.

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