Imaging biomarker roadmap for cancer studies
File(s)nrclinonc.2016.162.pdf (2.33 MB)
Published version
Author(s)
Type
Journal Article
Abstract
Imaging biomarkers (IBs) are integral to the routine management of patients with cancer. IBs used daily in oncology include clinical TNM stage, objective response and left ventricular ejection fraction. Other CT, MRI, PET and ultrasonography biomarkers are used extensively in cancer research and drug development. New IBs need to be established either as useful tools for testing research hypotheses in clinical trials and research studies, or as clinical decision-making tools for use in healthcare, by crossing 'translational gaps' through validation and qualification. Important differences exist between IBs and biospecimen-derived biomarkers and, therefore, the development of IBs requires a tailored 'roadmap'. Recognizing this need, Cancer Research UK (CRUK) and the European Organisation for Research and Treatment of Cancer (EORTC) assembled experts to review, debate and summarize the challenges of IB validation and qualification. This consensus group has produced 14 key recommendations for accelerating the clinical translation of IBs, which highlight the role of parallel (rather than sequential) tracks of technical (assay) validation, biological/clinical validation and assessment of cost-effectiveness; the need for IB standardization and accreditation systems; the need to continually revisit IB precision; an alternative framework for biological/clinical validation of IBs; and the essential requirements for multicentre studies to qualify IBs for clinical use.
Date Issued
2016-10-11
Date Acceptance
2016-10-01
Citation
Nature Reviews Clinical Oncology, 2016, 14, pp.169-186
ISSN
1759-4782
Publisher
Nature Publishing Group
Start Page
169
End Page
186
Journal / Book Title
Nature Reviews Clinical Oncology
Volume
14
Copyright Statement
© 2016 Macmillan Publishers Limited, part of Springer Nature. This work is licensed under a Creative Commons Attribution 4.0 International License. The images or other third party material in this article are included in the article's Creative Commons license, unless indicated otherwise in the credit line; if the material is not included under the Creative Commons license, users will need to obtain permission from the license holder to reproduce the material. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/.
Sponsor
Medical Research Council (MRC)
Cancer Research UK
Cancer Research UK
Engineering & Physical Science Research Council (EPSRC)
US Army (US)
Cancer Research UK
National Institute for Health Research
Scottish Power Foundation
Pfizer Limited
Commission of the European Communities
Cancer Research UK
Cancer Research UK
Cancer Research UK
Medical Research Council (MRC)
Cancer Research UK
Imperial College Healthcare NHS Trust- BRC Funding
Imperial College Healthcare NHS Trust- BRC Funding
Cancer Research UK
National Institute for Health Research
Imperial College Healthcare NHS Trust- BRC Funding
Imperial College Healthcare NHS Trust- BRC Funding
Imperial College Healthcare NHS Trust- BRC Funding
Medical Research Council (MRC)
Medical Research Council (MRC)
GlaxoSmithKline Services Unlimited
Grant Number
G0700915
C37/A9335
C2536/A10337
C2536/A10337
W81XWH-09-1-0097
C37990/A12196
NIHR/CS/009/009
4700192622
WS913975
115151
C37/A12011
WSCC_P34611
C2536/A16584
MR/J007986/1
C42671 / A12991
RDC04 79560
RDB01 79560
C42671 / A12993
EME/13/122/01
RDC04 79560
RDC04 79560
RDB03 79560
MC_PC15028
MR/N020782/1
Mark Buswell
Publication Status
Published