Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life endpoints
Measures of health-related quality of life and other patient-reported outcomes generate important data in cancer clinical trials which assist in evaluating the risks and benefits of cancer therapies, and fostering patient-centred cancer care. However, the various ways these measures are analysed and interpreted make it difficult to compare results across trials. This hinders the application of research findings to inform publications, product labelling, clinical guidelines and health policy. To address these problems, the Setting International Standards of Patient-Reported Outcomes and Quality of Life Endpoints in Cancer Clinical Trials – Innovative Medicines Initiative (SISAQOL-IMI) was established.
This international multidisciplinary consortium, convened by the European Organisation for Research and Treatment of Cancer (EORTC) 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.
SISAQOL-IMI kicked off at the beginning of January 2021 and will run for four years.