Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data for Cancer Clinical Trials

Measures of health-related quality of life (HRQL) and other patient-reported outcomes (PRO) generate important data in cancer randomized controlled trials (RCTs) to assist in evaluating the risks and benefits of cancer therapies, and fostering patient-centered cancer care. However, the various ways these measures are analyzed and interpreted make it difficult to compare results across trials, and hinders the application of research findings to inform publications, product labelling, clinical guidelines and health policy. To address these problems, the Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data (SISAQOL) initiative has been established. This international multidisciplinary consortium, directed by the European Organization for Research and Treatment of Cancer (EORTC), was convened to provide recommendations to standardize the analysis of HRQL and other PRO data in cancer RCTs. This article discusses the reasons why this project was initiated, the rationale for the planned work, and the expected benefits to cancer research, patient/provider decision-making, care delivery, and policymaking.