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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

Author's contributions: All of the authors contributed equally to the conception and write-up of the manuscript.

Sources of support: This study was supported by Genome Canada: Genome British Columbia, Genome Quebec, Canadian Institutes for Health Research (CIHR), Networks of Centres of Excellence Centre of Excellence for Commercialization and Research (CECR), St. Paul's Hospital Foundation, & the Canadian Respiratory Research Network (CRRN), 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.

DDS is a Tier 1 Canada Research Chair in COPD.

1Centre for Heart and Lung Innovation (James Hogg Research Centre), St. Paul’s Hospital, Vancouver, BC & the Institute for Heart + Lung Health, the University of British Columbia, Vancouver, BC

2Division of Respiratory Medicine (Department of Medicine), University of British Columbia, Vancouver, BC, Canada

3PROOF Center of Excellence, Vancouver, BC, Canada

4Department of Pathology and Laboratory Medicine, University of British Columbia, Vancouver, BC, Canada

5Centre for Clinical Epidemiology and Evaluation, Vancouver Coastal Health Research Institute, Vancouver, BC, Canada

6Department of Computer Sciences, the University of British Columbia, Vancouver, BC, Canada

Corresponding author: Don Sin, MD, MPH, St. Paul’s Hospital, 1081 Burrard Street, Vancouver, BC.


Copyright 2016, . All Rights Reserved.


Chest. 2016. doi:10.1016/j.chest.2016.09.012
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Abstract

There is a great interest in developing biomarkers to enable precision medicine and improve health outcomes of patients with chronic obstructive pulmonary disease (COPD). However, biomarker development is extremely challenging and expensive, and translation of research endeavors to date have been largely unsuccessful. In most cases, biomarkers fail owing to 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 the following 5 “SAVED” questions for optimal clinical translation. They include: 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 paper, 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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