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In 2009 the University Medicine Greifswald launched the Greifswald Approach to Individualized Medicine (GANI_MED) to implement biomarker-based individualized diagnostic and therapeutic strategies in clinical settings. Individualized Medicine (IM) has led not only to controversies about its potentials, but also about its societal, ethical and health economic implications. This anthology focusses on these areas and includes next to clinical examples illustrating how the integrated analysis of biomarkers leads to significant improvement of therapeutic outcomes for a subgroup of patients chapters about the definition, history and epistemology of IM. Additionally there is a focus on conceptual philosophical questions as well as challenges for applied research ethics (informed consent process, the IT-based consent management and the handling of incidental findings). Finally it pays attention to health economic aspects. The possibilities of IM to initiate a paradigm shift in the German health care provision are investigated. Furthermore, it is asked whether the G-DRG system is ready for the implementation of such approaches into clinical routine.
Preface
1 Introduction
Part I Definition and concept of Individualized Medicine
2 ?The meaning of Individualized Medicine A terminological adjustment of a perplexing term
3 ?Individualized Medicine within the GANI_MED project
Part II Perspectives of socio-cultural and historical studies?
4 ?Inventing traditions, raising expectations. Recent debates on Personalized Medicine
5 ?The Epistemics of Personalized Medicine. Rebranding pharmacogenetics
Part III Medical perspectives ?????????
6 ?Use of biomarkers for the prediction of treatment response: Immunoadsorption in dilated cardiomyopathy as a clinical example
7 ?The role of pharmacogenomiclC4
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