The important role of the histopathologist in clinical trials: challenges and approaches to tackle them

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 through every stage of research and clinical trials from concept development and study design, through trial delivery, to analysis and dissemination of results. Patient recruitment to trials takes place across all healthcare settings meaning 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 datasets 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 histopathologists are involved in clinical trials, 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).