Assessment of clinical trial protocols for pathology content using the SPIRIT-Path guidelines highlights areas for improvement
MetadataShow full item record
The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 Statement provides evidence-based recommendations for the minimum content of clinical trial protocols. The Cellular Molecular Pathology Initiative, hosted by the UK National Cancer Research Institute, developed an extension, SPIRIT-Path, describing how to effectively incorporate pathology support into clinical trial protocols. The current study assessed the inclusion of SPIRIT-Path items in protocols of active clinical trials. Publicly available clinical trial protocols were identified for assessment against the new guidelines using a single UK hospital as the ‘test site’. One hundred and ninety interventional clinical trials were identified as receiving support from the pathology department. However, only 38 had publicly available full trial protocols (20%) and following application of the inclusion/exclusion criteria, 19 were assessed against the SPIRIT-Path guidelines. The reviewed clinical trial protocols showed some areas of compliance and highlighted other items that were inadequately described. The latter lacked information about the individuals responsible for the pathology content of the trial protocol, how pathology activities and roles were organised in the trial, where the laboratory work would be carried out, and the accreditation status of the laboratory. Only one trial had information specific to digital pathology, a technology certain to become more prevalent in the future. Adoption of the SPIRIT-Path checklist will facilitate comprehensive trial protocols that address all the key cellular and molecular pathology aspects of interventional clinical trials. This study highlights once again the lack of public availability of trial protocols. Full trial protocols should be available for scrutiny by the scientific community and the public who participate in the studies, increasing the transparency of clinical trial activity and improving quality.
Robinson , P , Bacon , C , Lim , S , Shaaban , A , Brierley , D , Lewis , I , Harrison , D J , Kendall , T & Robinson , M 2022 , ' Assessment of clinical trial protocols for pathology content using the SPIRIT-Path guidelines highlights areas for improvement ' , Journal of Pathology , vol. Early View . https://doi.org/10.1002/cjp2.274
Journal of Pathology
Copyright © 2022 The Authors. The Journal of Pathology: Clinical Research published by The Pathological Society of Great Britain and Ireland and John Wiley & Sons Ltd. This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
DescriptionThe work was supported by a Pathological Society of Great Britain and Ireland Undergraduate Bursary awarded to PR. AS is supported by Birmingham Cancer Research UK Centre (C17422/A25154). The SPIRIT-Path project is part of the NCRI Pathology Group, formerly the CMPath initiative, and is funded by Blood Cancer UK, Breast Cancer Now, Cancer Research UK, Chief Scientist Office (Scotland), Department of Health and Social Care (England), Health and Care Research Wales, Public Health Agency (Northern Ireland), Medical Research Council, Prostate Cancer UK and Tenovus Cancer Care.
Items in the St Andrews Research Repository are protected by copyright, with all rights reserved, unless otherwise indicated.