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International Perspective on Health-Related Quality-of-Life Research in Cancer Clinical Trials: The European Organisation for Research and Treatment of Cancer Experience

Andrew Bottomley, Neil K. Aaronson

From the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Unit and Quality of Life Group, Brussels, Belgium; and Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, Amsterdam, the Netherlands

Address reprint requests to Andrew Bottomley, PhD, EORTC Quality of Life Unit, EORTC Data Center, Ave E. Mounier, 83, Box 11, Brussels, Belgium 1200; e-mail: andrew.bottomley{at}eortc.be

Over recent decades, health-related quality of life (HRQOL) research has been increasingly integrated into cancer clinical trials. The purpose of this review is to examine the overall approach taken towards clinical trial–based HRQOL investigations within the European Organisation for Research and Treatment of Cancer (EORTC). This article reports a literature review of clinical trial–based HRQOL investigations and provides selective examples of HRQOL studies in phase III clinical trials in various disease sites. The findings of this review highlight that, historically, assessing HRQOL was a challenge. However, as EORTC has become more experienced in the assessment of HRQOL and has developed a portfolio of appropriate tools, HRQOL has become a more accepted end point in large-scale trials. The trials reviewed in this article show that, in general, HRQOL data do provide information that can both inform clinicians about the effectiveness of the treatments and also serve as an invaluable source of information for patients to make informed decisions regarding the treatment choice.

Supported by Grants No. 2U10 CA11488-31 through 5U10 CA11488-37 from the National Cancer Institute, Bethesda, MD.

The contents of this article are solely the authors' responsibility and do not necessarily represent the official views of the National Cancer Institute.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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