Department of Histopathology, Addenbrookes Hospital, Cambridge, UK.
Cambridge NIH Biomedical Research Centre, Cambridge, UK.
Histopathology. 2020 Jun;76(7):942-949. doi: 10.1111/his.14099.
High-quality histopathology is essential for the success of clinical trials. Histopathologists have a detailed understanding of tumour biology and mechanisms of disease, as well as practical knowledge of optimal tissue handling and logistical service requirements for study delivery, such as biomarker evaluation, tissue acquisition and turnaround times. As such, histopathologist input is essential throughout every stage of research and clinical trials, from concept development and study design to trial delivery, analysis and dissemination of results. Patient recruitment to trials takes place among all healthcare settings, meaning that histopathologists make an invaluable contribution to clinical trials as part of their routine day-to-day work that often goes unrecognised. More complex evaluation of surgical specimens in the neoadjuvant setting and ever-expanding minimum data sets add to the workload of every histopathologist, not just academic pathologists in tertiary centres. This is occurring against a backdrop of increasing workload pressures and a worldwide shortage of histopathologists and biomedical scientists. Providing essential histopathology support for trials at grassroots level requires funding for adequate resources including histopathologist time, education and training, biomedical scientist and administrative support and greater recognition of the contribution made by histopathology. This paper will discuss the many ways in which histopathologists are involved in clinical trials and the challenges faced in meeting the additional demands posed by trial participation and potential ways to address this, with a special emphasis on the UK model and the Cellular-Molecular Pathology Initiative (CM-Path).
高质量的组织病理学对于临床试验的成功至关重要。组织病理学家对肿瘤生物学和疾病机制有详细的了解，并且对最佳组织处理和研究交付的后勤服务要求（如生物标志物评估、组织获取和周转时间）有实际的知识。因此，组织病理学家的意见在研究和临床试验的每个阶段都至关重要，从概念开发和研究设计到试验交付、分析和结果传播。临床试验的患者招募在所有医疗保健环境中进行，这意味着组织病理学家作为其日常工作的一部分，为临床试验做出了宝贵的贡献，而这些贡献往往未得到认可。在新辅助治疗环境中对手术标本进行更复杂的评估以及不断扩大的最小数据集增加了每位组织病理学家的工作量，而不仅仅是三级中心的学术病理学家。这是在工作量压力不断增加以及全球范围内组织病理学家和生物医学科学家短缺的背景下发生的。为基层临床试验提供必要的组织病理学支持需要为包括组织病理学家时间、教育和培训、生物医学科学家和行政支持在内的充足资源提供资金，并更充分地认识到组织病理学的贡献。本文将讨论组织病理学家参与临床试验的多种方式，以及在满足试验参与带来的额外需求方面面临的挑战，以及潜在的解决方法，特别强调英国模式和细胞-分子病理学倡议（CM-Path）。
