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 Harris; Denis 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

doi:10.1016/j.ejca.2019.03.025

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 journal › Article › Academic › peer-review

211 Downloads (Pure)

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 language	English
Pages (from-to)	128-136
Number of pages	9
Journal	European Journal of Cancer
Volume	114
DOIs	https://doi.org/10.1016/j.ejca.2019.03.025
Publication status	Published - Jun 2019

Keywords

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

Access to Document

10.1016/j.ejca.2019.03.025

Full TextFinal published version, 304 KBLicence: Taverne

Cite this

Salgado, R., Solit, D. B., Rimm, D. L., Bogaerts, J., Canetta, R., Lively, T., Lyerly, K., Span, P. N., Bateman-House, A., Makady, A., Bergmann, L., Nagai, S., Smith, C., Robson, M., Savage, M., Voest, E., Sweeney, C., Lambin, P., Thomas, M., ... IBCD-Faculty (2019). Addressing the dichotomy between individual and societal approaches to personalised medicine in oncology. European Journal of Cancer, 114, 128-136. https://doi.org/10.1016/j.ejca.2019.03.025

@article{398815b55505482cac3b18c5f224620e,

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. (C) 2019 Published by Elsevier Ltd.",

keywords = "Biomarkers, Evidence-driven optimal health-care delivery, Molecular and immunologic profiling, Health technology assessment, Clinical trials, GUIDELINES, ACCESS",

author = "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 Lyerly, {Herbert K.} and Laura Yee and David Rimm and Alison Bateman-Houseaj and Lothar Bergmann and Sumimasa Nagaiam and Marlene Thomasan and Cree, {Ian A.} and Shirley Hopper and Marc Robson and Magnus Ingelman-Sundberg and Francois Maignen and Benjamin Besse and Rafal Swierzewski and Astrid Kiermaier and Denis Lacombex and Tracy Livelyad and Christophe Massard and Roberto Salgadobf and Vassilis Golfinopoulos and IBCD-Faculty",

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",

volume = "114",

pages = "128--136",

journal = "European Journal of Cancer",

issn = "0959-8049",

publisher = "ELSEVIER SCI LTD",

}

Salgado, R, Solit, DB, Rimm, DL, Bogaerts, J, Canetta, R, Lively, T, Lyerly, K, Span, PN, Bateman-House, A, Makady, A, Bergmann, L, Nagai, S, Smith, C, Robson, M, Savage, M, Voest, E, Sweeney, C, Lambin, P, Thomas, M, Harris, L, Lacombe, D, Massard, C, Lyerly, HK, Yee, L, Rimm, D, Bateman-Houseaj, A, Bergmann, L, Nagaiam, S, Thomasan, M, Cree, IA, Hopper, S, Robson, M, Ingelman-Sundberg, M, Maignen, F, Besse, B, Swierzewski, R, Kiermaier, A, Lacombex, D, Livelyad, T, Massard, C, Salgadobf, R, Golfinopoulos, V & IBCD-Faculty 2019, 'Addressing the dichotomy between individual and societal approaches to personalised medicine in oncology', European Journal of Cancer, vol. 114, pp. 128-136. https://doi.org/10.1016/j.ejca.2019.03.025

TY - JOUR

T1 - Addressing the dichotomy between individual and societal approaches to personalised medicine in oncology

AU - Salgado, Roberto

AU - Solit, David B.

AU - Rimm, David L.

AU - Bogaerts, Jan

AU - Canetta, Renzo

AU - Lively, Tracy

AU - Lyerly, Kim

AU - Span, Paul N.

AU - Bateman-House, Alison

AU - Makady, Amr

AU - Bergmann, L.

AU - Nagai, Sumimasa

AU - Smith, Chris

AU - Robson, Mark

AU - Savage, Mary

AU - Voest, Emile

AU - Sweeney, Christopher

AU - Lambin, Philippe

AU - Thomas, Marlene

AU - Harris, Lyndsay

AU - Lacombe, Denis

AU - Massard, Chistophe

AU - Lyerly, Herbert K.

AU - Yee, Laura

AU - Rimm, David

AU - Bateman-Houseaj, Alison

AU - Bergmann, Lothar

AU - Nagaiam, Sumimasa

AU - Thomasan, Marlene

AU - Cree, Ian A.

AU - Hopper, Shirley

AU - Robson, Marc

AU - Ingelman-Sundberg, Magnus

AU - Maignen, Francois

AU - Besse, Benjamin

AU - Swierzewski, Rafal

AU - Kiermaier, Astrid

AU - Lacombex, Denis

AU - Livelyad, Tracy

AU - Massard, Christophe

AU - Salgadobf, Roberto

AU - Golfinopoulos, Vassilis

AU - IBCD-Faculty

N1 - 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: © 2019

PY - 2019/6

Y1 - 2019/6

N2 - 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.

AB - 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.

KW - Biomarkers

KW - Evidence-driven optimal health-care delivery

KW - Molecular and immunologic profiling

KW - Health technology assessment

KW - Clinical trials

KW - GUIDELINES

KW - ACCESS

U2 - 10.1016/j.ejca.2019.03.025

DO - 10.1016/j.ejca.2019.03.025

M3 - Article

SN - 0959-8049

VL - 114

SP - 128

EP - 136

JO - European Journal of Cancer

JF - European Journal of Cancer

ER -