The use of digital pathology and image analysis in clinical trials
The use of digital pathology and image analysis in clinical trials
复制标题
数字病理学和图像分析在临床试验中的应用
DOI：
10.1002/cjp2.127
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发表时间：
2019-04-01
影响因子：
4.1
通讯作者：
Morden, James
中科院分区：
文献类型：
--
作者：
Pell, Robert;Oien, Karin;Morden, James
数字病理和图像分析有可能为基于病理的试验进入标准和终点提供更高的准确性、可重复性和标准化，同时从现有的和新的特征中提取新的见解。与病理学评估相比，图像分析在更详细地识别、提取和量化特征方面具有巨大的潜力，这可能会产生改进的预测模型或执行超出人工能力的任务。在这篇文章中，我们概述了这些技术在临床试验中的应用，并讨论了潜在的应用、当前的挑战、限制和在这些研究中常规采用之前需要解决的尚未解决的问题。我们重申临床试验中病理中心综述的价值，并讨论使用数字化方法的内在后勤、成本和性能优势。概述了当前和正在出现的监管格局。讨论了数字平台和远程学习在提高临床试验病理学家培训和绩效方面的作用。描述了图像分析对定量组织形态计量学在关键领域的影响，如免疫组织化学染色解释的标准化，分子分析应用之前的肿瘤细胞性评估和新组织学特征的评估。数字图像制作的标准化、在临床前和临床研究中建立数字病理学使用标准、建立图像分析算法的性能标准以及与监管机构联系以促进将图像分析应用纳入临床实践是改善将数字病理学纳入临床试验的关键问题。
Digital pathology and image analysis potentially provide greater accuracy, reproducibility and standardisation of pathology-based trial entry criteria and endpoints, alongside extracting new insights from both existing and novel features. Image analysis has great potential to identify, extract and quantify features in greater detail in comparison to pathologist assessment, which may produce improved prediction models or perform tasks beyond manual capability. In this article, we provide an overview of the utility of such technologies in clinical trials and provide a discussion of the potential applications, current challenges, limitations and remaining unanswered questions that require addressing prior to routine adoption in such studies. We reiterate the value of central review of pathology in clinical trials, and discuss inherent logistical, cost and performance advantages of using a digital approach. The current and emerging regulatory landscape is outlined. The role of digital platforms and remote learning to improve the training and performance of clinical trial pathologists is discussed. The impact of image analysis on quantitative tissue morphometrics in key areas such as standardisation of immunohistochemical stain interpretation, assessment of tumour cellularity prior to molecular analytical applications and the assessment of novel histological features is described. The standardisation of digital image production, establishment of criteria for digital pathology use in pre-clinical and clinical studies, establishment of performance criteria for image analysis algorithms and liaison with regulatory bodies to facilitate incorporation of image analysis applications into clinical practice are key issues to be addressed to improve digital pathology incorporation into clinical trials.