Quality of life evaluation in oncological clinical trials - the EORTC model

The European Organization for Research and Treatment of Cancer (EORTC) has taken a leading role in the development of the methodology of quality of li fe (QL) measurement. In the EORTC Quality of Life Study Group (QLSG) valid instruments to assess QL in a general manner and disease-specific modules h ave been developed to be used in oncological clinical trials. Statistical a nd methodological aspects of QL research are discussed. The application of QL assessments in clinical trials represents a subsequent challenge. To imp rove the practice of QL assessment in clinical trials an 'EORTC model' has been developed. This model requires the collaboration of liaison persons, t he EORTC Cooperative Tumour Groups and the EORTC Data Centre Quality of Lif e Unit (QL Unit). Cooperation between these parties, protocol development a nd advantages and concerns of the model are mentioned in this paper. Finall y, suggestions for improvement are proposed. (C) 2000 Elsevier Science Ltd. All rights reserved.