The challenges and achievements involved in implementing Quality of Life research in cancer clinical trials

Over the last decade, Quality of Life (QOL) research has become an important aspect of cancer clinical trials. A dramatically increasing number of published studies, both randomised and non-randomised, report QOL outcomes. There is increasing evidence that QOL results impact on both future research and treatment decisions for clinicians. The rising number of studies with QOL components is mirrored within the European Organization for Research and Treatment of Cancer (EORTC), one of the largest cancer clinical trial organisations in Europe. Clinical trial groups have frequently reported on the difficulties and challenges of implementing QOL research. In the following paper, we therefore examine past experience in EORTC QOL studies, with a focus on the challenges presented and the improved approaches that are being implemented to obtain more meaningful outcomes. (C) 2003 Elsevier Science Ltd. All rights reserved.