Principal investigator(s)
Andrew Bottomley
Brussels, Belgium
, Ingolf Griebsch
Boehringer Ingelheim International GmbH
Ingelheim am Rhein, Germany
Project coordinator(s)
Madeline Pe
Brussels, Belgium
, Ahu Alanya
Brussels, Belgium

Project summary

The Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data (SISAQOL-IMI) Consortium has been convened by the European Organisation for Research and Treatment of Cancer (EORTC) and Boehringer Ingelheim (BI) with the aim to establish international standards on how to analyse, interpret and report PRO data gathered in cancer clinical trials. SISAQOL-IMI kicked off at the beginning of January 2021 and will run for four years.

In addition to producing international recommendations on how to analyse, interpret and report PRO data in cancer clinical trials, SISAQOL-IMI will also address the optimal use of PRO and gain clarity on PRO research objectives, including the definition of “clinically meaningful change”. Finally, SISAQOL-IMI aims to improve communication of PRO data through the standardisation of how findings are reported/displayed and through the creation of a suite of educational tools and materials for a range of audiences. To be successful, these recommendations will be supported by a broad consensus across stakeholders, balancing different needs, requirements, and perspectives. Thus, the work of SISAQOL-IMI will facilitate standardization of the analysis of PRO in cancer clinical trials and result in more reliable findings, improved interpretability, and faster dissemination of data, stemming from higher quality statistical methods.

SISAQOL-IMI is the follow-on consortium of SISAQOL 2016. The Setting International Standards in Analysing Patient-Reported Outcomes and Quality of Life Endpoints (SISAQOL) consortium was convened by the EORTC in 2016 and engaged various international stakeholders (regulators, health technology assessment bodies, payers, clinicians, methodological and applied statisticians, PRO experts, and patient representatives) to develop recommendations on the lack of standards in the evaluation of PRO findings in cancer randomised controlled trials.

The SISAQOL-IMI Consortium will build on the previous work of the SISAQOL consortium by further broadening the engagement of stakeholder groups, harmonising available recommendations, and updating them based on stakeholder needs and recent developments in the methodological literature.

To learn more about the work of the SISAQOL-IMI Consortium, please visit the SISAQOL-IMI website.



  • Bottomley A, Pe M, Sloan J, et al. Analysing data from patient-reported outcome and quality of life endpoints for cancer clinical trials: a start in setting international standards. Lancet Oncol. 2016;17(11):e510-e514. doi:10.1016/S1470-2045(16)30510-1.