Guidelines for cellular and molecular pathology content in clinical trial protocols : the SPIRIT-Path extension
Abstract
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.
Citation
Kendall , T J , Robinson , M , Brierley , D J , Lim , S J , O'Connor , D J , Shaaban , A M , Lewis , I , Chan , A-W , Harrison , D J & SPIRIT-Path group 2021 , ' Guidelines for cellular and molecular pathology content in clinical trial protocols : the SPIRIT-Path extension ' , The Lancet Oncology , vol. 22 , no. 10 , e435-e445 . https://doi.org/10.1016/S1470-2045(21)00344-2
Publication
The Lancet Oncology
Status
Peer reviewed
ISSN
1470-2045Type
Journal article
Description
This Series paper was funded by the NCRI through the CMPath initiative. MS is supported by the Birmingham Cancer Research UK Centre (C17422/A25154). The SPIRIT-Path project is part of the NCRI 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 the Tenovus Cancer Care.Collections
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