Perspective † Author for correspondence Andrew Bottomley † , PhD, Co-ordinator, Quality of Life Unit, EORTC Data Center, Avenue E. Mounier 83/11, 1200 Brussels, Belgium Tel.: +32 2 774 16 61 Fax: +32 2 779 45 68 abo@eortc.be Henning Flechtner, MD, Clinic for Psychiatry and Psychotherapy of Children and Adolescents, University of Cologne, Robert-Koch-Str. 10, 50931 Cologne, Germany Tel.: +49 221 478 6121 Fax: +49 221 478 6104, henning.flechtner@medizin.uni-koeln.de © Future Drugs Ltd. All rights reserved. ISSN 1473-7167 84 Quality of life in oncology clinical trials: present and future challenges ‘We have to come down from our ‘methodological ivory towers’ and just occasionally, work on explaining exactly what QoL is and how it can be useful to clinicians.’ Expert Rev. Pharmacoeconomics Outcomes Res . 2(2), 84–86 (2002) Many of us in the quality of life (QoL) field have spent hours arguing with clinicians about the value of QoL. This is never more of a chal- lenge than in oncology. For many years, oncol- ogists have said, ‘Why bother with quality of life assessment, in our clinical trials? ’ ‘What’s the point? ’ ‘Its more effort than its worth.’ ‘Whether the patient lives or dies is the most important issue for us, not soft QoL data ’. While these statements may have been true some years ago, over the last decade, we have seen a huge surge of interest in QoL assessment in the clinical trial oncology community. QoL is now becoming so important that a great number of present day clinical trials include it, usually as a secondary, but occasionally as a primary end- point. In the European Organisation for Research and Treatment of Cancer (EORTC), one of the largest cancer clinical trial groups in Europe, we now include QoL in well over 60% of all Phase III clinical trials. It is now clear that some oncologist’s views are slowly warming to the idea of QoL in cancer clinical trials. One fundamental point which has perhaps encouraged clinicians to look more positively on Q oL may have emerged from the very posi- tive views expressed by organizations, such as American Society of Clinical Oncology (ASCO) and the Food and Drug Administra- tion (FDA) in the early 1990s. At this time, these bodies made recommendations related to the ‘added value’ of Q oL and its use as a suita- ble end-point in cancer clinical trials. In addi- tion, more recently, we have seen oncology journals reviewing clinical trial papers and requesting authors for QoL data. Of course, this makes perfect sense in diseases, such as lung, brain or advanced breast cancer, where survival improvements may be extremely lim- ited. We increasingly see only limited survival increases, measured in some cases in terms of weeks or months. In such instances, it makes sense to evaluate just how valuable to the patient those added days of survival are, against the potential toxic effects of treatment. Perhaps it is also noteworthy that we have seen an increase in the use of QoL data in clinical tri- als, possibly due to the added value that this can provide to pharmaceutical and other medical industries. T hat is, with QoL data, this can succeed in prov- ing the added value of a particular treat- ment, over that which may not be available from the routine col- lection of clinical data. For example, some oncology treatments may improve fatigue, or improve sexual functioning or libido. QoL data can also help the pharmaceutical industry pro- duce more accurate labeling, which in turn can assist clinicians and patients understand the overall benefits from treatments. One example where the pharmaceutical industry has harnessed ‘For many years, oncologists have said, ‘ Why bother with quality of life assessment, in our clinical trials?’ ‘ What’s the point?’ ‘ Its more effort than its worth .’