Evaluating Health-Related Quality of Life in Cancer Clinical Trials: The National Cancer Institute of Canada Clinical Trials Group Experience
Article first published online: 8 NOV 2007
Value in Health
Special Issue: The FDA Guidance for Patient-Reported Outcomes
Volume 10, Issue Supplement s2, pages S138–S145, November/December 2007
How to Cite
Osoba, D., Bezjak, A., Brundage, M. and Pater, J. (2007), Evaluating Health-Related Quality of Life in Cancer Clinical Trials: The National Cancer Institute of Canada Clinical Trials Group Experience. Value in Health, 10: S138–S145. doi: 10.1111/j.1524-4733.2007.00278.x
- Issue published online: 8 NOV 2007
- Article first published online: 8 NOV 2007
- clinical trials;
- quality of life
Introduction: The National Cancer Institute of Canada (NCIC) Clinical Trials Group (CTG) Quality of Life (QOL) Committee was initiated in 1986.
Purpose: 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.
Recommendations: 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.