List of Figures

ix

List of Tables

xi

Notes on Contributors

xiii

Introduction / Jan Schildmann

1

pt. I

PERSONALISED MEDICINE -- MEDICINE FOR THE PERSON? CONCEPTS AND CONTEXTUAL ASPECTS

1.

What is Personalised Medicine? Sharpening a Vague Term Based on a Systematic literature Review / Georg Marckmann

9

2.

Alarming Symptoms of a Paradigm Shift? An Approach to Bridge the Gap between Hypothetical Ethics and the Current Status of Individualised Medicine Research / Martin Langanke

25

3.

Personalised Medicine: Getting Past the Controversies / George P. Browman

41

4.

Patient as Person in Personalised Medicine: Autonomy, Responsibility and the Body / Thomas Wabel

53

5.

The Authority of Corporeality and Emotions: The New Phenomenology and its Relevance to the German Debate on Personalised Medicine / Mathias Wirth

65

6.

Towards Integration of `Personalised' and `Person-Centred' Medicine: The Concept of `Integrative and Personalised Health Care' / Peter Heusser

77

pt. II

PERSONALISED MEDICINE IN CLINICAL AND PRACTICAL RESEARCH

7.

Ethical Considerations for Developing a Best-Practice Guideline for Next Generation Sequencing in Oncology / Christof von Kalle

87

8.

Practice Variation across Consent Templates for Biobank Research: A Survey of German Biobanks / Daniel Strech

97

9.

Individualised Medicine in the Diagnosis and Prognosis of Patients Younger than 65 Years with Normal Karyotype Acute Myeloid Leukemia: A Systematic Review and Meta-Analysis of the Impact of Fms-Related Tyrosine Kinase 3 Internal Tandem Duplication (FLT3-ITD) / Anja Neumann

113

10.

Taking it Personally: Patients' Perspectives on Personalised Medicine and its Ethical Relevance / Silke Schicktanz

129

11.

`Personalised Medicine' in Oncology: Physicians' Perspectives on Contributions to and Challenges for Clinical Practice / Jochen Vollmann

149

12.

Through Thick and Big: Data-Rich Medicine in the Era of Personalisation / Barbara Prainsack

161

pt. III

PERSONALISED MEDICINE IN HEALTH-CARE SYSTEMS

13.

Benefit Assessment of Personalised Interventions: Methodological Challenges and Approaches to a Solution / Stefan Lange

175

14.

The Relevance of the Analytic Validity of Genetic Biomarker Tests in Personalised Medicine in Oncology / Franz Hessel

187

15.

Approval and Reimbursement of Personalised Drugs: Interim Results of the Adjustment Process / Jurgen Wasem

199

16.

Criteria for Fairly Allocating Scarce Health-Care Resources to Genetic Tests: Which Matter Most? / Georg Marckmann

211

17.

Personalised Medicine as Orphan Drugs? Legal and Ethical Questions / Stefan Huster

231

18.

Personalised Medicine: Priority Setting and Opportunity Costs in European Public Health-Care Systems / Jochen Vollmann

245

pt. IV

PERSONALISED MEDICINE IN ONCOLOGY: RECOMMENDATIONS FOR FUTURE DEVELOPMENT

19.

`Personalised Medicine': Multidisciplinary Perspectives and Interdisciplinary Recommendations on a Framework for Future Research and Practice / Jochen Vollmann

259

Index

281