Added value of health-related quality of life measurement in cancer clinical trials: the experience of the NCIC CTG
- 1 April 2010
- journal article
- review article
- Published by Informa UK Limited in Expert Review of Pharmacoeconomics & Outcomes Research
- Vol. 10 (2), 119-128
- https://doi.org/10.1586/erp.10.15
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
This publication has 69 references indexed in Scilit:
- Quality of life data as prognostic indicators of survival in cancer patients: an overview of the literature from 1982 to 2008Health and Quality of Life Outcomes, 2009
- New response evaluation criteria in solid tumours: Revised RECIST guideline (version 1.1)European Journal Of Cancer, 2009
- K-rasMutations and Benefit from Cetuximab in Advanced Colorectal CancerNew England Journal of Medicine, 2008
- The Patient-Reported Outcomes Measurement Information System (PROMIS)Medical Care, 2007
- The paradox of response and survival in cancer therapeuticsBlood, 2006
- Erlotinib in Previously Treated Non–Small-Cell Lung CancerNew England Journal of Medicine, 2005
- Radiotherapy plus Concomitant and Adjuvant Temozolomide for GlioblastomaNew England Journal of Medicine, 2005
- A Randomized Trial of Letrozole in Postmenopausal Women after Five Years of Tamoxifen Therapy for Early-Stage Breast CancerNew England Journal of Medicine, 2003
- Randomized Intergroup Trial of Cisplatin-Paclitaxel Versus Cisplatin-Cyclophosphamide in Women With Advanced Epithelial Ovarian Cancer: Three-Year ResultsJNCI Journal of the National Cancer Institute, 2000
- The European Organization for Research and Treatment of Cancer QLQ-C30: A Quality-of-Life Instrument for Use in International Clinical Trials in OncologyJNCI Journal of the National Cancer Institute, 1993