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The important role of the histopathologist in clinical trials: challenges and approaches to tackle them
Author(s) -
Provenzano Elena,
Driskell Owen J,
O'Connor Daniel J,
RodriguezJusto Manuel,
McDermott Jacqueline,
Wong Newton,
Kendall Timothy,
Zhang Yu Zhi,
Robinson Max,
Kurian Kathreena M,
Pell Robert,
Shaaban Abeer M
Publication year - 2020
Publication title -
histopathology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.626
H-Index - 124
eISSN - 1365-2559
pISSN - 0309-0167
DOI - 10.1111/his.14099
Subject(s) - workload , clinical trial , turnaround time , medicine , medical education , pathology , computer science , operations management , engineering , operating system
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).