@article{1cb8c305a7204590a96c79aff860288c,
title = "Addressing the dichotomy between individual and societal approaches to personalised medicine in oncology",
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",
author = "{the IBCD-Faculty} and Roberto Salgado and Solit, {David B.} and Rimm, {David L.} and Jan Bogaerts and Renzo Canetta and Tracy Lively and Kim Lyerly and Span, {Paul N.} and Alison Bateman-House and Amr Makady and L. Bergmann and Sumimasa Nagai and Chris Smith and Mark Robson and Mary Savage and Emile Voest and Christopher Sweeney and Philippe Lambin and Marlene Thomas and Lyndsay Harris and Denis Lacombe and Chistophe Massard and Rene Bernards and Richard Sullivan and Sabine Tejpar and Nina Lukinova and Lyerly, {Herbert K.} and Helen Moore and Smith, {Malcolm A.} and Laura Yee and Ray DuBois and Hahn, {William C.} and Pasi Janne and Willman, {Cheryl L.} and David Rimm and Lothar Bergmann and Cree, {Ian A.} and Priti Hegde and Shirley Hopper and Marc Robson and Magnus Ingelman-Sundberg and Gwen Nichols and Francois Maignen and Benjamin Besse and Rafal Swierzewski and Astrid Kiermaier and Christophe Massard and Michael Caliguri and Victor Velculescu and Paolo Foggi",
note = "Funding Information: The views represented in the article represent the views of the individual authors and not necessarily those of the different organisations of the faculty to whom the authors belong. Medical writing assistance was provided by John Bean PhD, Bean Medical Writing, Halle, Belgium and was funded by EORTC . The IBCD 2018 conference was managed by Davi Kaur, Danielle Zimmerman, Said Laghmari, Laurence Decroix, Frederic Rince and Gwydion Lyn of the EORTC Communication and Events Team, Brussels, Belgium. Publisher Copyright: {\textcopyright} 2019",
year = "2019",
month = jun,
doi = "10.1016/j.ejca.2019.03.025",
language = "English (US)",
volume = "114",
pages = "128--136",
journal = "European Journal of Cancer",
issn = "0959-8049",
publisher = "Elsevier Limited",
}