The acute respiratory distress syndrome biomarker pipeline: crippling gaps between discovery and clinical utility.
Pubmed ID: 32599095
Pubmed Central ID: PMC7319618
Journal: Translational research : the journal of laboratory and clinical medicine
Publication Date: 12/01/2020
Affiliation: College of Medicine, University of Arizona Health Sciences, Tucson, Arizona.
MeSH Terms: Humans, Biomarkers, Translational Medical Research, Betacoronavirus, COVID-19, Coronavirus Infections, Pandemics, Pneumonia, Viral, Respiratory Distress Syndrome, SARS-CoV-2
Grants: K08 HL141623, R42 HL145930, R41 HL147769, P01 HL126609, P01 HL134610
Authors: Bime C, Garcia JGN, Casanova N, Oita RC, Ndukum J, Lynn H, Camp SM
Cite As: Bime C, Camp SM, Casanova N, Oita RC, Ndukum J, Lynn H, Garcia JGN. The acute respiratory distress syndrome biomarker pipeline: crippling gaps between discovery and clinical utility. Transl Res 2020 Dec;226:105-115. Epub 2020 Jun 26.
Recent innovations in translational research have ushered an exponential increase in the discovery of novel biomarkers, thereby elevating the hope for deeper insights into "personalized" medicine approaches to disease phenotyping and care. However, a critical gap exists between the fast pace of biomarker discovery and the successful translation to clinical use. This gap underscores the fundamental biomarker conundrum across various acute and chronic disorders: how does a biomarker address a specific unmet need? Additionally, the gap highlights the need to shift the paradigm from a focus on biomarker discovery to greater translational impact and the need for a more streamlined drug approval process. The unmet need for biomarkers in acute respiratory distress syndrome (ARDS) is for reliable and validated biomarkers that minimize heterogeneity and allow for stratification of subject selection for enrollment in clinical trials of tailored therapies. This unmet need is particularly highlighted by the ongoing SARS-CoV-2/COVID-19 pandemic. The unprecedented numbers of COVID-19-induced ARDS cases has strained health care systems across the world and exposed the need for biomarkers that would accelerate drug development and the successful phenotyping of COVID-19-infected patients at risk for development of ARDS and ARDS mortality. Accordingly, this review discusses the current state of ARDS biomarkers in the context of the drug development pipeline and highlight gaps between biomarker discovery and clinical implementation while proposing potential paths forward. We discuss potential ARDS biomarkers by category and by context of use, highlighting progress in the development continuum. We conclude by discussing challenges to successful translation of biomarker candidates to clinical impact and proposing possible novel strategies.