This past March 2009, Ms. Lily Claassens completed a two year fellowship in the QOL Department at EORTC Headquarters. The fellowship concerned understanding QOL in cancer patients and received an unrestricted educational grant from AstraZeneca pharmaceuticals, UK.
During her fellowship, Ms. Claassens contributed to the success of several QOL Department projects. She conducted a qualitative study of the FDA and EMEA regulations for patient-reported outcomes measures and end-points in clinical trials (1). This work has major implications for policy regarding quality of life endpoints when used for the registration of new compounds, and it highlighted differences between FDA and EMEA policy.
Ms. Claassens also conducted a second project, in collaboration with three EORTC groups (EORTC Brain Cancer, Radiation Oncology, and Quality of Life) and the National Cancer Institute of Canada Clinical Trials Group (NCIC-CTG). This research involved a detailed psychometric analysis of the health-related QOL data collected from the EORTC 26951 and EORTC 26981 trials in order to fully validate the EORTC QLQ-BN20, perhaps the most commonly used health-related QOL tool used in brain cancer. This tool will have major benefits for researchers in the future when examining brain cancer patients’ health-related QOL and symptoms in cancer clinical trials.
Finally, for her third project, Ms. Claassens undertook an intensive systematic Cochrane style review of the literature on the health related QOL methodology and the clinical impact in randomized controlled trials in non-small cell lung cancer patients. These results were selected for presentation at ASCO this summer and demonstrate the need to continue to improve the manner in which international groups conduct randomized controlled trials as well as the importance using of health related QOL data in non-small cell lung cancer for key treatment decision making.
Because of her QOL fellowship experience, Ms. Claassens was able to secure a position as Junior Researcher in the Department of Medical Psychology and Psychotherapy (MPP) at the Erasmus Medical Centre, in Rotterdam, the Netherlands. In this position she will be occupied with psychological and ethical issues concerning organ donation and QOL. Ms. Claassens will continue to collaborate actively with the QOL Department on several projects. We wish Ms. Claassens success in her new position and in her future career.
(1) Bottomley A, Jones D, Claassens L. Patient-reported outcomes: Assessment and current perspectives of the guidelines of the Food and Drug Administration and the reflection paper of the European Medicines Agency. Eur J Cancer 2009; 45(3): 347-53.