tailieunhanh - Health and Quality of Life Outcomes BioMed Central Commentary Open Access Surrogate end points of

Health and Quality of Life Outcomes BioMed Central Commentary Open Access Surrogate end points of quality of life assessment: have we really found what we are looking for? Davide Tassinari* Address: Department of Oncology, City Hospital, viale Settembrini, 47900, Rimini, Italy Email: Davide Tassinari* - dtassinari@ * Corresponding author Published: 24 November 2003 Health and Quality of Life Outcomes 2003, 1:71 This article is available from: Received: 25 July 2003 Accepted: 24 November 2003 © 2003 Tassinari; licensee BioMed Central Ltd. This is an Open Access article: verbatim copying and redistribution of this article are permitted in all media for any purpose, provided this notice is preserved along. | BioMed Central Health and Quality of Life Outcomes Commentary Open Access Surrogate end points of quality of life assessment have we really found what we are looking for Davide Tassinari Address Department of Oncology City Hospital viale Settembrini 47900 Rimini Italy Email Davide Tassinari - dtassinari@ Corresponding author Published 24 November 2003 Received 25 July 2003 Accepted 24 November 2003 Health and Quality of Life Outcomes 2003 1 71 r This article is available from http content 1 1 71 2003 Tassinari licensee BioMed Central Ltd. This is an Open Access article verbatim copying and redistribution of this article are permitted in all media for any purpose provided this notice is preserved along with the article s original URL. Abstract Outcome research is a new interesting field in medical research. Some years ago a document of the American Society of Clinical Oncology distinguished the outcomes of a treatment into patientoutcomes overall survival and quality of life and cancer-outcomes response rate giving higher priority to patient outcomes. This document is one of the best structured instruments to evaluate and classify the outcomes in clinical oncology. Nevertheless although overall survival and quality of life represent the main patient outcomes in clinical oncology in the last years many researchers tried to overcome these recommendations creating new surrogate end points to assess overall survival and quality of life. Surrogate end points can be useful tools when they are used to achieve preliminary data that anticipate the evaluation of the final outcome but the use of surrogate end points instead of the main outcomes is quite dangerous as it can provide wrong answers to clinical questions. The use or abuse of surrogate end points of quality of life has recently favoured some questionable decisions of the main regulator organs such as the approval by the Food and Drugs Administration of the use of gemcitabine in advanced .