Bringing science and the patient perspective together: The SISAQOL-IMI consortium launches standards and tools for patient-reported endpoints (PRO) in cancer clinical trials

SISAQOL-IMI (Setting International Standards of Patient-Reported Outcomes and Quality of Life Endpoints in Cancer Clinical Trials) is pleased to announce the publication of the central article in The Lancet Oncology, along with the release of a number of useful tools.

SISAQOL-IMI is an international, multidisciplinary consortium of 41 partner organisations led by the European Organisation for Research and Treatment of Cancer (EORTC) and Boehringer Ingelheim (BI) and formed under the Innovative Medicines Initiative (IMI). The publication of the SISAQOL-IMI results marks the conclusion of a four-year collaborative project that aimed to develop standardized guidelines for the design, analysis, interpretation and presentation of patient-reported outcome data (PRO) in clinical cancer trials.

Oslo University Hospital HF has been an active partner in the consortium and leading package 7, which was responsible for the consensus process and the final project deliverables. OUS co-authors on the SISAQOL-IMI publication are Cecilie Delphin Amdal (first author), Ragnhild Falk, Kenth-Louis Hansen Joseph and Kristin Bjordal (joint last author) .

SISAQOL-IMI's online tools are available on the SISAQOL-IMI website and via a link on the Regional Research Support website.

In 2026 and 2027, the consortium will continue its work on developing support tools and training materials that will follow the recommendations.

The purpose of the project was to achieve consensus in the international scientific community on how to design, analyze, interpret and present patient-reported data (results from "quality of life studies") in clinical cancer studies. A number of such guidelines already existed, but there were small differences between them and none covered the entire research field. In this project, all important international players, including the FDA, EMA, industry partners and a number of academic groups and patient representatives, have jointly agreed on a consensus-based set of recommendations important for cancer clinical research and research dissemination in the years to come.

For Kristin Bjordal, this has been a laborious and tiring, but incredibly fun and rewarding end to her 35 years of participation in this research field 

OUS has been an active partner with four researchers from Research Support Services (Forskningsstøtte/FST). Educational for everyone, and this will now be implemented in our environments.

Links:

Comprehensive article (in Norwegian), from the Research Support Services homepage:
SISAQOL-IMI forener vitenskapen og pasientperspektivet! (by Kristin Bjordal)

The Lancet article:
Amdal CD, Falk RS, Alanya A, Schlichting M, Roychoudhury S, Bhatnagar V, Wintner LM, Regnault A, Ingelgård A, Coens C, le Cessie S, Holzner B, Chang J, Taphoorn M, Cislo P, Giesinger JM, Cappelleri JC, Pawar V, Ten Seldam S, Papadopoulos EJ, Calvert MJ, Joseph KL, Bottomley A, Griebsch I, Arraras JI et al. (2025)
SISAQOL-IMI consensus-based guidelines to design, analyse, interpret, and present patient-reported outcomes in cancer clinical trials
Lancet Oncol, 26 (12), e683-e693
DOI 10.1016/S1470-2045(25)00520-0, PubMed 41308689

The project's international home page:
https://www.sisaqol-imi.org/

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