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

Timothy J Kendall; Max Robinson; Daniel J Brierley; Shujing Jane Lim; Daniel J O'Connor; Abeer M Shaaban; Ian Lewis; An-Wen Chan; David J Harrison; SPIRIT-Path group

doi:10.1016/S1470-2045(21)00344-2

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

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

Research output: Contribution to journal › Article › peer-review

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.

Original language	English
Article number	e435-e445
Number of pages	11
Journal	The Lancet Oncology
Volume	22
Issue number	10
Early online date	27 Sept 2021
DOIs	https://doi.org/10.1016/S1470-2045(21)00344-2
Publication status	Published - Oct 2021

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Copyright © 2021 Elsevier Ltd. All rights reserved. This work has been made available online in accordance with publisher policies or with permission. Permission for further reuse of this content should be sought from the publisher or the rights holder. This is the author created accepted manuscript following peer review and may differ slightly from the final published version. The final published version of this work is available at https://doi.org/10.1016/S1470-2045(21)00344-2.
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Cite this

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title = "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.",

author = "Kendall, {Timothy J} and Max Robinson and Brierley, {Daniel J} and Lim, {Shujing Jane} and O'Connor, {Daniel J} and Shaaban, {Abeer M} and Ian Lewis and An-Wen Chan and Harrison, {David J} and {SPIRIT-Path group}",

note = "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.",

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AU - Shaaban, Abeer M

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AU - Chan, An-Wen

AU - Harrison, David J

AU - SPIRIT-Path group

N1 - 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.

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JO - The Lancet Oncology

JF - The Lancet Oncology

IS - 10

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ER -

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

Abstract

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