title: The challenges and achievements involved in implementing Quality of Life research in cancer clinical trials.
abstract: 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.
authors.affiliation: Quality of Life Unit, on behalf of the EORTC Quality of Life Group and the EORTC Data Center, EORTC Data Center, Avenue E. Mounier 83/11, 1200, Brussels, Belgium. abo@eortc@be
authors.forename: A
authors.initials: A
authors.lastname: Bottomley
authors.forename: V
authors.initials: V
authors.lastname: Vanvoorden
authors.forename: H
authors.initials: H
authors.lastname: Flechtner
authors.forename: P
authors.initials: P
authors.lastname: Therasse
mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods*; D003431:Cross-Cultural Comparison; D003625:Data Collection / Q000379:methods; D006801:Humans; D009369:Neoplasms / Q000628:therapy*; D010349:Patient Compliance; D017410:Practice Guidelines as Topic; D011788:Quality of Life; D012106:Research