Guidelines for cellular and molecular pathology content in clinical trial protocols: the SPIRIT-Path extension

Timothy J. Kendall*, Max Robinson, Daniel Brierley, Shujing Jane Lim, Daniel O'Connor, Abeer M Shaaban, Ian Lewis, An-Wen Chan, David Harrison

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

Abstract

The SPIRIT 2013 Statement provides evidence-based recommendations for the minimum content of clinical trial protocols. Assessment of biospecimens is often required for trial eligibility or as part of outcome evaluation, and precision molecular approaches are increasingly used in trial design. However, cellular and molecular pathology practices within trials have neither been codified nor 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 assessing candidate items generated from a prior 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, 7 extensions to the SPIRIT checklist and 7 elaborations, that should be addressed in trial protocols with 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 protocol, including all stages of the specimen pathway, any digital pathology methods, and with specific consideration of the value of trial data and tissue for additional translational studies.
Original languageEnglish
JournalThe Lancet Oncology
Early online date27 Sep 2021
DOIs
Publication statusE-pub ahead of print - 27 Sep 2021

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