Department of Cellular Pathology, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, UK.
Division of Surgery and Interventional Sciences, University College London, London, UK.
J Pathol Clin Res. 2021 May;7(3):191-202. doi: 10.1002/cjp2.199. Epub 2021 Feb 26.
The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 Statement was developed to provide guidance for inclusion of key methodological components in clinical trial protocols. However, these standards do not include guidance specific to pathology input in clinical trials. This systematic review aims to synthesise existing recommendations specific to pathology practice in clinical trials for implementation in trial protocol design. Articles were identified from database searches and deemed eligible for inclusion if they contained: (1) guidance and/or a checklist, which was (2) pathology-related, with (3) content relevant to clinical trial protocols or could influence a clinical trial protocol design from a pathology perspective and (4) were published in 1996 or later. The quality of individual papers was assessed using the AGREE-GRS (Appraisal of Guidelines for REsearch & Evaluation - Global Rating Scale) tool, and the confidence in cumulative evidence was evaluated using the GRADE-CERQual (Grading of Recommendations Assessment, Development and Evaluation-Confidence in Evidence from Reviews of Qualitative research) approach. Extracted recommendations were synthesised using the best fit framework method, which includes thematic analysis followed by a meta-aggregative approach to synthesis within the framework. Of the 10 184 records screened and 199 full-text articles reviewed, only 40 guidance resources met the eligibility criteria for inclusion. Recommendations extracted from 22 guidance documents were generalisable enough for data synthesis. Seven recommendation statements were synthesised as follows: (1) multidisciplinary collaboration in trial design with early involvement of pathologists, particularly with respect to the use of biospecimens and associated biomarker/analytical assays and in the evaluation of pathology-related parameters; (2) funding and training for personnel undertaking trial work; (3) selection of an accredited laboratory with suitable facilities to undertake scheduled work; (4) quality assurance of pathology-related parameters; (5) transparent reporting of pathology-related parameters; (6) policies regarding informatics and tracking biospecimens across trial sites; and (7) informed consent for specimen collection and retention for future research.
SPIRIT（标准协议项目：干预试验建议）2013 年声明旨在为临床试验方案中纳入关键方法学内容提供指导。然而，这些标准不包括临床试验中病理学输入的具体指导。本系统评价旨在综合现有关于临床试验中病理学实践的建议，以便纳入试验方案设计。从数据库搜索中确定了文章，如果它们包含：（1）指导和/或检查表，（2）与病理学相关，（3）与临床试验方案相关的内容，或（4）从病理学角度影响临床试验方案设计，并且（4）在 1996 年或之后发表，则被认为符合纳入标准。使用 AGREE-GRS（评估研究和评价指南-全球评分量表）工具评估个别论文的质量，并使用 GRADE-CERQual（推荐评估、制定和评估-来自定性研究的证据置信度）方法评估累积证据的置信度。使用最佳拟合框架方法综合提取的建议，该方法包括主题分析，然后在框架内采用元聚合方法进行综合。在筛选的 100184 条记录和 199 篇全文文章中，只有 40 条指南资源符合纳入标准。从 22 份指南文件中提取的建议具有足够的概括性，可以进行数据综合。综合了以下 7 条建议：（1）在试验设计中进行多学科合作，早期让病理学家参与，特别是在使用生物样本和相关生物标志物/分析检测以及评估与病理学相关的参数方面；（2）为从事试验工作的人员提供资金和培训；（3）选择具有适当设施的经过认证的实验室进行计划工作；（4）保证与病理学相关的参数的质量；（5）透明报告与病理学相关的参数；（6）关于信息学和在试验点跟踪生物样本的政策；以及（7）对样本采集和保留用于未来研究的知情同意。
