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Translating Basic Research Into Clinical Practice |

Biomarker Development in COPD: Moving From P Values to Products to Impact Patient Care

Zsuzsanna Hollander, PhD; Mari L. DeMarco, PhD; Mohsen Sadatsafavi, MD, PhD; Bruce M. McManus, MD, PhD; Raymond T. Ng, PhD; Don D. Sin, MD
Author and Funding Information

FUNDING/SUPPORT: This study was funded by Genome Canada: Genome British Columbia, Genome Quebec, the Canadian Institutes for Health Research (CIHR), the Networks of Centres of Excellence for Commercialization and Research, the St. Paul’s Hospital Foundation, and the Canadian Respiratory Research Network, which is funded by the Institute of Circulatory and Respiratory Health Emerging Network of CIHR, the Canadian Lung Association, the Canadian Thoracic Society, and the Canadian Respiratory Health Professionals; the British Columbia Lung Association; with industry partner funding from AstraZeneca, Boehringer-Ingelheim (Canada) Ltd., GlaxoSmithKline Inc., and Novartis Pharmaceuticals Canada Inc.

aCentre for Heart and Lung Innovation, James Hogg Research Centre, St. Paul’s Hospital, Vancouver, BC, Canada

bInstitute for Heart + Lung Health, University of British Columbia, Vancouver, BC, Canada

cDivision of Respiratory Medicine, Department of Medicine, University of British Columbia, Vancouver, BC, Canada

dDepartment of Pathology and Laboratory Medicine, University of British Columbia, Vancouver, BC, Canada

eDepartment of Computer Sciences, University of British Columbia, Vancouver, BC, Canada

fPROOF Centre of Excellence, Vancouver, BC, Canada

gCentre for Clinical Epidemiology and Evaluation, Vancouver Coastal Health Research Institute, Vancouver, BC, Canada

CORRESPONDENCE TO: Don D. Sin, MD, St. Paul’s Hospital, 1081 Burrard St, Vancouver, BC, Canada V6Z 1Y6


Copyright 2016, American College of Chest Physicians. All Rights Reserved.


Chest. 2017;151(2):455-467. doi:10.1016/j.chest.2016.09.012
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There is a great interest in developing biomarkers to enable precision medicine and improve health outcomes of patients with COPD. However, biomarker development is extremely challenging and expensive, and translation of research endeavors to date has been largely unsuccessful. In most cases, biomarkers fail because of poor replication of initial promising results in independent cohorts and/or inability to transfer the biomarker from a discovery platform to a clinical assay. Ultimately, new biomarker assays must address 5 questions for optimal clinical translation. They include the following: is the biomarker likely to be (1) superior (will the test outperform current standards?); (2) actionable (will the test change patient management?); (3) valuable (will the test improve patient outcomes?); (4) economical (will the implementation of the biomarker in the target population be cost-saving or cost-effective?); and (5) clinically deployable (is there a pathway for the biomarker and analytical technology to be implemented in a clinical laboratory?)? In this article we review some of the major barriers to biomarker development in COPD and provide possible solutions to overcome these limitations, enabling translation of promising biomarkers from discovery experiments to clinical implementation.

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