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Eur J Cancer. 2019 Jun;114:128-136. doi: 10.1016/j.ejca.2019.03.025. Epub 2019 May 3.

Addressing the dichotomy between individual and societal approaches to personalised medicine in oncology.

Author information

1
Department of Pathology GZA-ZNA, Antwerp, Belgium; Division of Research, Peter Mac Callum Cancer Center, Melbourne, Australia. Electronic address: roberto@salgado.be.
2
Memorial Sloan Kettering Cancer Center, New York, NY, USA.
3
Dept. of Pathology, Yale University School of Medicine, New Haven, CT, USA; Dept. of Medicine, Yale University School of Medicine, New Haven, CT, USA.
4
EORTC Headquarters, Brussels, Belgium.
5
Independent Consultant, Madison, CT, USA.
6
National Cancer Institute, Bethesda, MD, USA.
7
Duke University, Durham, NC, USA.
8
Radiotherapy and OncoImmunology Laboratory, Department of Radiation Oncology, Radboud University Medical Center, Nijmegen, the Netherlands.
9
Division of Medical Ethics, NYU Langone Health, New York, NY, USA.
10
The National Healthcare Institute (ZIN), Diemen, the Netherlands.
11
Medical Clinic II, University Hospital Frankfurt, Germany; Ambulantes Krebszentrum Frankfurt, Germany.
12
Translational Research Center, The University of Tokyo Hospital and PMDA, Tokyo, Japan.
13
CRUK Cambridge Institute, University of Cambridge, Cambridge, United Kingdom.
14
Merck, Whitehouse Station, NJ, USA.
15
The Netherlands Cancer Institute, Amsterdam, the Netherlands.
16
Dana Farber Cancer Institute, Harvard Medical School, Boston, MA, USA.
17
The D-Lab & The M-Lab, Department of Precision Medicine, GROW Research Institute for Oncology, Maastricht, The Netherlands.
18
Roche, Basel, Switzerland.
19
Institut Gustave Roussy, Paris, France.
20
Netherlands Cancer Institute, Amsterdam, the Netherlands.
21
EORTC, Brussels, Belgium.
22
Independent Consultant, USA.
23
King's College London, London, UK.
24
U.Z. Leuven, Leuven, Belgium.
25
NCI, Rockville, MD, USA.
26
Duke University Medical Center, Durham, NC, USA.
27
National Cancer Institute (NCI), Bethesda, MD, USA.
28
Medical University of South Carolina, Charleston, SC, USA.
29
Dana-Farber Cancer Institute, Boston, MA, USA.
30
University of New Mexico, Albuquerque, NM, USA.
31
Dept. of Pathology, Yale University School of Medicine, New Haven, CT, USA.
32
Interne Geneeskunde Sector Zorg Zorginstituut Nederland, Diemen, the Netherlands.
33
Ambulantes Krebszentrum, Frankfurt, Germany.
34
IARC, Lyon, France.
35
Genentech, South San Francisco, CA, USA.
36
Medicines and Healthcare products Regulatory Agency, London, United Kingdom.
37
Karolinska Institut, Sweden.
38
The Leukemia & Lymphoma Society, New York, NY, USA.
39
NICE, London, United Kingdom.
40
ECPC, Belgium.
41
Maastricht University Medical Centre, Maastricht, the Netherlands.
42
Roche Innovation Center Basel, Basel, Switzerland.
43
City of Hope National Medical Center, Duarte, CA, USA.
44
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD, USA.
45
AACR, USA.
46
Dana Farber Cancer Institute, Boston, MA, USA.
47
Antwerp, Belgium; Melbourne, Australia.

Abstract

Academic, industry, regulatory leaders and patient advocates in cancer clinical research met in November 2018 at the Innovation and Biomarkers in Cancer Drug Development meeting in Brussels to address the existing dichotomy between increasing calls for personalised oncology approaches based on individual molecular profiles and the need to make resource and regulatory decisions at the societal level in differing health-care delivery systems around the globe. Novel clinical trial designs, the utility and limitations of real-world evidence (RWE) and emerging technologies for profiling patient tumours and tumour-derived DNA in plasma were discussed. While randomised clinical trials remain the gold standard approach to defining clinical utility of local and systemic therapeutic interventions, the broader adoption of comprehensive tumour profiling and novel trial designs coupled with RWE may allow patient and physician autonomy to be appropriately balanced with broader assessments of safety and overall societal benefit.

KEYWORDS:

Biomarkers; Clinical trials; Evidence-driven optimal health-care delivery; Health technology assessment; Molecular and immunologic profiling

PMID:
31060925
DOI:
10.1016/j.ejca.2019.03.025

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