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.

Keywords::

• cancer
• clinical trials
• health-related quality of life
• HRQoL
• oncology
• patient-reported outcomes
• PRO
• quality of life

Acknowledgements

The authors thank Neil Aaronson, EORTC Quality of Life Group, for his insightful contributions to our workshop, Anne Leis for her comments on an earlier draft of the manuscript, and Dina McMahon for her clerical support.

Financial & competing interests disclosure

The National Cancer Institute of Canada Clinical Trials Group is a cancer clinical trials cooperative group that independently conducts clinical trials research with funds provided by the Canadian Cancer Society. Additional funds are also received from other sources, which include the US National Cancer Institute/Cancer Therapy Evaluation Program, other peer-review agencies and industry contracts. Many of the trials described within this manuscript included funding support from the pharmaceutical industry. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.