{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,1]],"date-time":"2026-09-01T16:33:50Z","timestamp":1788280430284,"version":"build-2803163510"},"reference-count":32,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2020,5,30]],"date-time":"2020-05-30T00:00:00Z","timestamp":1590796800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Histopathology"],"published-print":{"date-parts":[[2020,6]]},"abstract":"<jats:p>High\u2010quality 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\u2010to\u2010day work that often goes unrecognised. More complex evaluation of surgical specimens in the neoadjuvant setting and ever\u2010expanding 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\u2013Molecular Pathology Initiative (CM\u2010Path).<\/jats:p>","DOI":"10.1111\/his.14099","type":"journal-article","created":{"date-parts":[[2020,3,7]],"date-time":"2020-03-07T17:44:06Z","timestamp":1583603046000},"page":"942-949","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":18,"title":["The important role of the histopathologist in clinical trials: challenges and approaches to tackle them"],"prefix":"10.1111","volume":"76","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3345-3965","authenticated-orcid":false,"given":"Elena","family":"Provenzano","sequence":"first","affiliation":[{"name":"Department of Histopathology Addenbrookes Hospital Cambridge UK"},{"name":"Cambridge NIH Biomedical Research Centre Cambridge UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Owen J","family":"Driskell","sequence":"additional","affiliation":[{"name":"National Institute for Health Research Clinical Research Network West Midlands Albrighton UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel J","family":"O'Connor","sequence":"additional","affiliation":[{"name":"Medicines and Healthcare Products Regulatory Agency (MHRA) London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Manuel","family":"Rodriguez\u2010Justo","sequence":"additional","affiliation":[{"name":"Department Research Pathology Cancer Institute University College London London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jacqueline","family":"McDermott","sequence":"additional","affiliation":[{"name":"Department of Cellular Pathology University College London Hospital London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9537-4106","authenticated-orcid":false,"given":"Newton","family":"Wong","sequence":"additional","affiliation":[{"name":"Department of Cellular Pathology Southmead Hospital Bristol UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4174-2786","authenticated-orcid":false,"given":"Timothy","family":"Kendall","sequence":"additional","affiliation":[{"name":"Centre for Inflammation Research and Edinburgh Pathology University of Edinburgh Edinburgh UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yu Zhi","family":"Zhang","sequence":"additional","affiliation":[{"name":"National Centre for Mesothelioma Research National Heart and Lung Institute Imperial College London London UK"},{"name":"Department of Histopathology Royal Brompton and Harefield NHS Foundation Trust London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Max","family":"Robinson","sequence":"additional","affiliation":[{"name":"Centre for Oral Health Research Newcastle University Newcastle UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kathreena M","family":"Kurian","sequence":"additional","affiliation":[{"name":"Brain Tumour Research Centre University of Bristol Bristol UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert","family":"Pell","sequence":"additional","affiliation":[{"name":"Buckinghamshire Healthcare NHS Trust Amersham UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Abeer M","family":"Shaaban","sequence":"additional","affiliation":[{"name":"Queen Elizabeth Hospital Birmingham Birmingham UK"},{"name":"University of Birmingham Birmingham UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2020,5,30]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12916-015-0472-7"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1158\/1078-0432.CCR-15-1961"},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.2217\/fon.15.335"},{"key":"e_1_2_7_5_1","doi-asserted-by":"publisher","DOI":"10.1038\/modpathol.2015.74"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.1186\/1741-7015-10-51"},{"key":"e_1_2_7_7_1","unstructured":"ICH Biomarkers related to Drug or Biotechnology Product Development: Context Structure and Format of Qualification Submissions.2010. 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