Translational Medicine, Genentech, San Francisco, California, USA.
Roche Pharma Research and Early Development, Roche Innovation Center Basel, Basel, Switzerland.
Cytometry A. 2024 Nov;105(11):829-837. doi: 10.1002/cyto.a.24902. Epub 2024 Oct 23.
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.
临床生物标志物策略越来越多地整合转化研究，以深入了解疾病机制或在临床试验中定义更好的生物标志物。高维流式细胞术（HDFCM）有望超越传统的靶向生物标志物策略，增强探索潜力。然而，HDFCM 的复杂性增加带来了几个挑战，需要加以解决，以充分发挥其潜力，并符合临床流式细胞术当前的监管要求。这些挑战包括但不限于延长检测方法的开发和验证时间、对 HDFCM 有广泛的了解的必要性，以及复杂的数据分析策略。然而，在采用临床 HDFCM 时，如何应对这些挑战尚无指导方针。我们在 CYTO 2024 研讨会“临床高维流式细胞术的潜力和挑战”上旨在就 HDFCM 在临床试验中的总体优势和最紧迫挑战在制药行业和更广泛的科学界达成共识。在这里，我们总结了从研讨会中获得的见解。虽然本报告没有提供蓝图，但它是在临床试验中实施 HDFCM 定义和总结最紧迫挑战的第一步。此外，我们还汇编了当前的努力，以克服其中的一些挑战。因此，我们将科学界和卫生当局聚集在一起，共同制定解决方案，这将加速和简化临床研究中 HDFCM 的全面采用。
