Biomarker Development in COPD: Moving From P Values to Products to Impact Patient Care.
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.
Centre for Heart and Lung Innovation, James Hogg Research Centre, St. Paul's Hospital, Vancouver, BC, Canada; Institute for Heart + Lung Health, University of British Columbia, Vancouver, BC, Canada; PROOF Centre of Excellence, Vancouver, BC, Canada.
Zsuzsanna
Z
Hollander
Department of Pathology and Laboratory Medicine, University of British Columbia, Vancouver, BC, Canada.
Mari L
ML
DeMarco
Institute for Heart + Lung Health, University of British Columbia, Vancouver, BC, Canada; Centre for Clinical Epidemiology and Evaluation, Vancouver Coastal Health Research Institute, Vancouver, BC, Canada.
Mohsen
M
Sadatsafavi
Centre for Heart and Lung Innovation, James Hogg Research Centre, St. Paul's Hospital, Vancouver, BC, Canada; Institute for Heart + Lung Health, University of British Columbia, Vancouver, BC, Canada; Department of Pathology and Laboratory Medicine, University of British Columbia, Vancouver, BC, Canada; PROOF Centre of Excellence, Vancouver, BC, Canada.
Bruce M
BM
McManus
Centre for Heart and Lung Innovation, James Hogg Research Centre, St. Paul's Hospital, Vancouver, BC, Canada; Institute for Heart + Lung Health, University of British Columbia, Vancouver, BC, Canada; Department of Computer Sciences, University of British Columbia, Vancouver, BC, Canada; PROOF Centre of Excellence, Vancouver, BC, Canada.
Raymond T
RT
Ng
Centre for Heart and Lung Innovation, James Hogg Research Centre, St. Paul's Hospital, Vancouver, BC, Canada; Institute for Heart + Lung Health, University of British Columbia, Vancouver, BC, Canada; Division of Respiratory Medicine, Department of Medicine, University of British Columbia, Vancouver, BC, Canada. Electronic address: Don.Sin@hli.ubc.ca.
Don D
DD
Sin
D015415:Biomarkers / Q000378:metabolism*; D003362:Cost-Benefit Analysis; D018450:Disease Progression; D005541:Forced Expiratory Volume; D006801:Humans; D057285:Precision Medicine; D029424:Pulmonary Disease, Chronic Obstructive / Q000175:diagnosis / Q000378:metabolism* / Q000503:physiopathology; D057170:Translational Research, Biomedical; D016896:Treatment Outcome
D015415:Biomarkers
COPD; biomarkers; personalized medicine