What is quality of life? Clinical trials have long been dominated by clinically based endpoints, but research has proved that health-related quality of life (HRQOL) can only be captured accurately by patients themselves using patient reported outcomes (PROs). The United States Food and Drug Administration defines PROs as the measurement of any aspect of a patient’s health status that comes directly from the patient, that is, a measurement taken without interpretation of the patient’s responses by a physician or anyone else. The EORTC QLQ-C30 is the most widely cancer specific HRQOL questionnaire used for PROs in the world. Developed in 1991 by the EORTC Quality of Life Group, it has been translated into more than 60 languages and has over 40 developed or under development cancer specific modules. One of the key challenges faced is pooling data and performing meta-analyses of the results of closed trials. The EORTC Patient Reported Outcomes and Behavioural Evidence (PROBE) team is dedicated to the meta-analysis of EORTC randomised clinical trial quality of life results. During the last five years, pooled data have revealed important results, such as prognostic indicators of survival, which haveinformed clinical practice. This research shows how the patient perspective in palliative and curative EORTC trials has been considered of major importance. The inclusion of patient perspective in drug development shows that a more comprehensive HRQOL assessment has taken place over time as better instruments have become available. As clinicians, regulatory bodies and industry acknowledge the value of the patient perspective, we expect that EORTC will continue including HRQOL endpoints where appropriate.
Efstathios Zikos, Corneel Coens, John Bean, Divine Ediebah, Andrew Bottomley
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