Setting International Standards in
Analysing Patient-Reported Outcomes
and Quality of Life Endpoints


Measures of health-related quality of life (HRQOL) and other patient-reported outcomes (PRO) in cancer clinical trials generate important data used to evaluate benefits and risks of cancer therapies and foster patient-centred cancer care. However, the various ways these measures are analysed and interpreted make it difficult to compare results across clinical trials. This hinders the application of research findings to inform publications, product labelling, clinical guidelines, health policy and regulatory decisions. To address these problems, the Setting International Standards in Analysing Patient-Reported Outcomes and Quality of Life endpoints – Innovative Medicines Initiative (SISAQOL-IMI) was established.
This international multidisciplinary project consortium, convened by the European Organisation for Research and Treatment of Cancer (EORTC) and Boehringer Ingelheim (BI) will 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.

The challenge

With patient-centred and personalised care gaining a more central role in cancer care, and in the regulation of medicines, PROs, including HRQOL, are increasingly being captured in cancer clinical trials to provide valuable information on treatment risks, benefits and tolerability.

Diverse ways of analysing, interpreting, and reporting PRO data hinders comparability and credibility of results across trials. Subsequent inconsistencies in the results cause inefficient resource use, fragmented reporting, and interpretational barriers.


The goal of SISAQOL-IMI is to create international recommendations on how to analyse, interpret and report PRO data in cancer clinical trials. It will also address the optimal use of PRO and gain clarity on PRO research objectives, including the definition of “clinically meaningful change.”

To be successful, these recommendations will be supported by a broad consensus across stakeholders, balancing different needs, requirements, and perspectives. It is hoped that these standards will facilitate an alignment in analysis of PRO and result in more reliable findings, improved interpretability, and faster dissemination of data, stemming from higher quality statistical methods.

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.


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 Consortium, see the links below.

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