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SISAQOL-IMI Sets Standards for Cancer Trial Patient-Reported Data

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International consortium to provide recommendations for understanding PRO data in cancer clinical trials

International consortium to provide recommendations for understanding PRO data in cancer clinical trials
An international multidisciplinary consortium, co-led by the European Organisation for Research and Treatment of Cancer (EORTC) and Boehringer Ingelheim (BI), 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 (Setting International Standards of Patient-Reported Outcomes and Quality of Life Endpoints in Cancer Clinical Trials - 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, analyzed in a statistically adequate manner, and intelligibly presented to ensure a high study quality and better comparability of results across clinical trials. ....

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