SISAQOL-IMI (Setting International Standards in Analysing Patient-Reported Outcomes and Quality of Life Endpoints in Cancer Clinical Trials – IMI) is an international multidisciplinary consortium, co-led by the European Organization for Research and Treatment of Cancer (EORTC) and Boehringer Ingelheim (BI). The consortium has been convened to generate recommendations to standardize the use, analysis, and interpretation of patient reported outcome (PRO) data in cancer clinical trials.

SISAQOL-IMI will establish guidance on how to use patient-reported outcomes in cancer clinical trials so that they can be used in a methodologically sound way, analysed in a statistically adequate manner, and intelligibly presented to ensure a high study quality and a better comparability of results across clinical trials.

This four-year collaborative project will develop a set of standards for the design, analysis, interpretation, and presentation of patient-reported outcome (PRO) data for cancer clinical trials. This project and its generated recommendations will be of critical importance to organisations like the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA), as PRO data presented uniformly across trials and cancers will help support fair and informed decision making. Robust and meaningful PRO data may also lead to improved shared decision-making between patients and their treating physicians. This in turn may lead to improved patient satisfaction, an increased likelihood of adherence to treatment, higher likelihood of treatment success, and a reduction in health-care cost.