Potential and challenges of clinical high‐dimensional flow cytometry: A call to action

Clinical biomarker strategies increasingly integrate translational research to gain new insights into disease mechanisms or to define better biomarkers in clinical trials. High‐dimensional flow cytometry (HDFCM) holds the promise to enhance the exploratory potential beyond traditional, targeted biom...

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Veröffentlicht in:Cytometry. Part A 2024-11, Vol.105 (11), p.829-837
Hauptverfasser: Liechti, Thomas, Lelios, Iva, Schroeder, Aaron, Decman, Vilma, Gonneau, Christele, Groves, Christopher, Green, Cherie, Alcaide, Enrique Gomez
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container_end_page 837
container_issue 11
container_start_page 829
container_title Cytometry. Part A
container_volume 105
creator Liechti, Thomas
Lelios, Iva
Schroeder, Aaron
Decman, Vilma
Gonneau, Christele
Groves, Christopher
Green, Cherie
Alcaide, Enrique Gomez
description Clinical biomarker strategies increasingly integrate translational research to gain new insights into disease mechanisms or to define better biomarkers in clinical trials. High‐dimensional flow cytometry (HDFCM) holds the promise to enhance the exploratory potential beyond traditional, targeted biomarker strategies. However, the increased complexity of HDFCM poses several challenges, which need to be addressed in order to fully leverage its potential and to align with current regulatory requirements in clinical flow cytometry. These challenges include among others extended timelines for assay development and validation, the necessity for extensive knowledge in HDFCM, and sophisticated data analysis strategies. However, no guidelines exist on how to manage such challenges in adopting clinical HDFCM. Our CYTO 2024 workshop “Potential and challenges of clinical high‐dimensional flow cytometry” aimed to find consensus across the pharmaceutical industry and broader scientific community on the overall benefits and most urgent challenges of HDFCM in clinical trials. Here, we summarize the insights we gained from our workshop. While this report does not provide a blueprint, it is a first step in defining and summarizing the most pressing challenges in implementing HDFCM in clinical trials. Furthermore, we compile current efforts with the goal to overcome some of these challenges. As such we bring the scientific community and health authorities together to build solutions, which will accelerate and simplify the full adoption of HDFCM in clinical trials.
doi_str_mv 10.1002/cyto.a.24902
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source MEDLINE; Wiley Blackwell Single Titles
subjects assay validation
Biomarkers
Clinical trials
Clinical Trials as Topic
Data analysis
Flow cytometry
Flow Cytometry - methods
high‐dimensional flow cytometry
Humans
Knowledge management
Pharmaceutical industry
spectral flow cytometry
standardization
Translational Research, Biomedical - methods
unsupervised data analysis
Workshops
title Potential and challenges of clinical high‐dimensional flow cytometry: A call to action
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