Health and Quality of Life Outcomes BioMed Central Commentary Open Access Clinical and Outcome Research in oncology The need for integration Giovanni Apolone* Address: Istituto di Ricerche Farmacologiche "Mario Negri" (Milan, Italy) Email: Giovanni Apolone* - apolone@ * Corresponding author Published: 3 April 2003 Health and Quality of Life Outcomes 2003, 1:3 This article is available from: Received: 27 February 2003 Accepted: 3 April 2003 © 2003 Apolone; 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 Cancer is one of the. | BioMed Central Health and Quality of Life Outcomes Commentary Clinical and Outcome Research in oncology The need for integration Giovanni Apolone Address Istituto di Ricerche Farmacologiche Mario Negri Milan Italy Email Giovanni Apolone - apolone@ Corresponding author Open Access Published 3 April 2003 Received 27 February 2003 Accepted 3 April 2003 Health and Quality of Life Outcomes 2003 1 3 This article is available from http content 1 1 3 2003 Apolone 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 Cancer is one of the main healthcare problems in Europe. Although significant progress has recently been made long-term survival is still disappointing for most common solid tumours. The explosion of information has strengthened the need to create and sustain coordinated interaction between technology biology clinical research clinical practice and health policy. A simple process based on automatic and passive translation from bench to clinical research and eventually to the bed side is usually assumed but cannot be taken for granted. A critical role might be played by Outcome Research OR defined as the discipline that describes interprets and predicts the impact of various influences especially interventions on final endpoints from survival to satisfaction with care that matter to decision makers from patients to society at large with special emphasis on the use of patient-reported outcomes PRO . Recently under pressure from several parts of society the FDA recognizing the need for faster drug approval has modified existing regulations and created new rules to allow anti-cancer drugs to be approved more quickly and in certain but quite common circumstances single arm trials and surrogate endpoints to be used as measures of clinical benefit. In this .
