Evaluating health-related quality of life in cancer clinical trials: the National Cancer Institute of Canada Clinical Trials Group experience.
BACKGROUND
The National Cancer Institute of Canada (NCIC) Clinical Trials Group (CTG) Quality of Life (QOL) Committee was initiated in 1986.


OBJECTIVE
The purpose of this review is to describe the evolution of the Committee's work and to highlight key developments such as the formulation of a policy regarding health-related quality-of-life (HRQOL) assessment, the provision of guidelines to ensure completion of HRQOL data within the protocol requirements, the rationale behind the choice of HRQOL instruments, the timing of assessments and the development of data analytic methods. These developments are illustrated with examples from CTG studies.


CONCLUSIONS
There is a lack of concordance between conventional toxicity data and HRQOL data and comparative studies designed to elucidate these differences are to be encouraged. Also, more studies are required to compare different analytic strategies and to determine how much missing data is acceptable, particularly in oncology studies where attrition is inevitable.
Osoba
David
D
QOL Consulting, West Vancouver, BC, Canada. david_osoba@telus.net
Bezjak
Andrea
A
Brundage
Michael
M
Pater
Joseph
J
D002170:Canada; D017326:Clinical Trials, Phase III as Topic / Q000379:methods*; D003625:Data Collection / Q000379:methods; D003627:Data Interpretation, Statistical; D006801:Humans; D009369:Neoplasms / Q000188:drug therapy*; D011788:Quality of Life; D015203:Reproducibility of Results; D011795:Surveys and Questionnaires; D016896:Treatment Outcome