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 |
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container_title | Cytometry. Part A |
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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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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. 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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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