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

Roberto Salgado*, David B. Solit, David L. Rimm, Jan Bogaerts, Renzo Canetta, Tracy Lively, Kim Lyerly, Paul N. Span, Alison Bateman-House, Amr Makady, L. Bergmann, Sumimasa Nagai, Chris Smith, Mark Robson, Mary Savage, Emile Voest, Christopher Sweeney, Philippe Lambin, Marlene Thomas, Lyndsay HarrisDenis Lacombe, Chistophe Massard, Herbert K. Lyerly, Laura Yee, David Rimm, Alison Bateman-Houseaj, Lothar Bergmann, Sumimasa Nagaiam, Marlene Thomasan, Ian A. Cree, Shirley Hopper, Marc Robson, Magnus Ingelman-Sundberg, Francois Maignen, Benjamin Besse, Rafal Swierzewski, Astrid Kiermaier, Denis Lacombex, Tracy Livelyad, Christophe Massard, Roberto Salgadobf, Vassilis Golfinopoulos, IBCD-Faculty

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

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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. (C) 2019 Published by Elsevier Ltd.

Original languageEnglish
Pages (from-to)128-136
Number of pages9
JournalEuropean Journal of Cancer
Volume114
DOIs
Publication statusPublished - Jun 2019

Keywords

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

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