Guidelines for cellular and molecular pathology content in clinical trial protocols: the SPIRIT-Path extension
Guidelines for cellular and molecular pathology content in clinical trial protocols: the SPIRIT-Path extension
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DOI：
10.1016/s1470-2045(21)00344-2
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发表时间：
2021-10-01
期刊：
影响因子：
51.1
通讯作者：
Harrison, David J.
中科院分区：
文献类型：
--
作者：
Kendall, Timothy J.;Robinson, Max;Harrison, David J.
2013年SPIRIT（标准方案项目：介入试验建议）声明为临床试验方案中应包含的最低内容提供了循证建议。生物样本的评估通常需要试验合格性或作为结果评价的一部分，并且精密分子方法越来越多地用于试验设计。然而，试验中的细胞和分子病理学实践尚未编纂或正式化。我们使用国际德尔菲程序制定了临床试验方案中细胞和分子病理学内容的国际共识报告指南（SPIRIT-Path扩展），该程序评估了先前系统评价产生的候选项目，随后召开专家共识会议。来自五大洲的74名个人做出了回应，包括临床医生、统计学家、实验室科学家、患者倡导者、资助者、行业代表、期刊编辑和监管机构。SPIRIT-Path指南推荐了14个额外项目（SPIRIT检查表的7个扩展和7个详细说明），这些项目应在包含病理学内容的试验方案中与SPIRIT 2013声明项目一起解决。SPIRIT-Path建议，方案应记录试验所有细胞和分子病理学组成部分的个人、过程和标准，包括标本途径的所有阶段和任何数字病理学方法，并特别考虑试验数据和生物组织对额外转化研究的价值。
The 2013 SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) Statement provides evidence-based recommendations for the minimum content to be included in a clinical trial protocol. Assessment of biospecimens is often required for trial eligibility or as part of an outcome evaluation, and precision molecular approaches are increasingly used in trial design. However, cellular and molecular pathology practices within trials have not been codified or formalised. We developed international consensus reporting guidelines for cellular and molecular pathology content in clinical trial protocols (the SPIRIT-Path extension) using an international Delphi process, which assesses candidate items generated from a previous systematic review, followed by an expert consensus meeting. 74 individuals from five continents responded, including clinicians, statisticians, laboratory scientists, patient advocates, funders, industry representatives, journal editors, and regulators. The SPIRIT-Path guidelines recommend 14 additional items (seven extensions to the SPIRIT checklist and seven elaborations) that should be addressed in trial protocols containing pathology content, alongside the SPIRIT 2013 Statement items. SPIRIT-Path recommends that protocols should document the individuals, processes, and standards for all cellular and molecular pathology components of the trial, including all stages of the specimen pathway and any digital pathology methods, with specific consideration of the value of trial data and biological tissues for additional translational studies.