QUALITY-OF-LIFE ASSESSMENT IN PEDIATRIC ONCOLOGY - A RETROSPECTIVE REVIEW OF PHASE-III REPORTS

Background: although the quality of life of cancer patients has been a topic of increasing interest, the research literature to date has generally noted minimal reporting of these data in adult clinical trials. Purpose: the purpose of this investigation was to examine the frequency with which these measures are reported in pediatric cancer clinical trials. Method: published reports of 70 Phase III clinical trials from the Pediatric Oncology Group and Childrens Cancer Group were reviewed for presentation of quality of life and toxicity data. Results: approximately 3% of these reports included quality of life data, while toxicities were noted for over 75%. Conclusions: quality of life endpoints are not reflected in clinical trial reports. Education as to the potential usefulness of these data, as well as recognition of the barriers that exist to using such measures must be addressed.