title: Added value of health-related quality of life measurement in cancer clinical trials: the experience of the NCIC CTG.
abstract: Health-related quality-of-life (HRQoL) data are often included in Phase III clinical trials. We evaluate and classify the value added to Phase III trials by HRQoL outcomes, through a review of the National Cancer Institute of Canada Clinical Trials Group clinical trials experience within various cancer patient populations. HRQoL may add value in a variety of ways, including the provision of data that may contrast with or may support the primary study outcome; or that assess a unique perspective or subgroup, not addressed by the primary outcome. Thus, HRQoL data may change the study's interpretation. Even in situations where HRQoL measurement does not alter the clinical interpretation of a trial, important methodologic advances can be made. A classification of the added value of HRQoL information is provided, which may assist in choosing trials for which measurement of HRQoL outcomes will be beneficial.
authors.affiliation: Department of Medical Oncology, Cross Cancer Institute, 11560 University Avenue, Edmonton, AB T6G 1Z2, Canada. heather-jane.au@albertahealthservices.ca
authors.forename: Heather-Jane
authors.initials: HJ
authors.lastname: Au
authors.forename: Jolie
authors.initials: J
authors.lastname: Ringash
authors.forename: Michael
authors.initials: M
authors.lastname: Brundage
authors.forename: Michael
authors.initials: M
authors.lastname: Palmer
authors.forename: Harriet
authors.initials: H
authors.lastname: Richardson
authors.forename: Ralph M
authors.initials: RM
authors.lastname: Meyer
mesh_terms: D002170:Canada; D017326:Clinical Trials, Phase III as Topic / Q000379:methods*; D003625:Data Collection / Q000379:methods; D003627:Data Interpretation, Statistical; D023381:Endpoint Determination; D006304:Health Status; D006801:Humans; D009369:Neoplasms / Q000628:therapy*; D011788:Quality of Life