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

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

doi:10.1016/s1470-2045(21)00344-2

Cited by 18 publications

(18 citation statements)

References 32 publications

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“…“There is increasing recognition of the need for pathologists to be involved early in trial planning and design to ensure methodological rigor in trials requiring sample collection, procurement, storage, transportation and analysis” ( 42 ). The recommendations for Interventional Trials 2013 Statement has recently been expanded to include Pathology (SPIRIT-Path) ( 43 ). “The guidelines allow investigators to comprehensively address the cellular and molecular pathology aspects of trial protocols, ensuring adequate skills and resources are available at trial commencement and fully leverage the value of biospecimens for translational research” ( 43 ).…”

Section: Promoting Cancer Clinical Trials In Ssamentioning

confidence: 99%

“…The recommendations for Interventional Trials 2013 Statement has recently been expanded to include Pathology (SPIRIT-Path) ( 43 ). “The guidelines allow investigators to comprehensively address the cellular and molecular pathology aspects of trial protocols, ensuring adequate skills and resources are available at trial commencement and fully leverage the value of biospecimens for translational research” ( 43 ).…”

Section: Promoting Cancer Clinical Trials In Ssamentioning

confidence: 99%

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Promoting Best Practice in Cancer Care in Sub Saharan Africa

Sharma

Sayed²,

Saleh³

2022

Front. Med.

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Promoting best practice in the management of a cancer patient is rooted in the application of new knowledge derived through various sources including population science, laboratory advances, and translational research. Ultimately, the impact of these advances depends on their application at the patient's bedside. A close collaboration between the oncologist and the pathologist is critical in underwriting progress in the management of the cancer patient. Recent advancements have shown that more granular characteristics of the tumor and the microenvironment are defining determinants when it comes to disease course and overall outcome. Whereas, histologic features and basic immunohistochemical characterization were previously adequate to define the tumor and establish treatment recommendation, the growing capability of the pathologist to provide molecular characterization of the tumor and its microenvironment, as well as, the availability of novel therapeutic agents have revolutionized cancer treatment paradigms and improved patient-outcomes and survival. While such capacity and capability appear readily available in most developed high-income countries (HIC), it will take a concerted and collaborative effort of all stakeholders to pave the way in the same stride in the low and middle-income countries (LMIC), which bear a disproportionate burden of human illness and cancers. Patients in the LMIC present with disease at advanced stage and often display characteristics unlike those encountered in the developed world. To keep stride and avoid the disenfranchisement of patients in the LMIC will require greater participation of LMIC patients on the global clinical trial platform, and a more equitable and affordable sharing of diagnostic and therapeutic capabilities between the developed and developing world. Key to the success of this progress and improvement of patient outcomes in the developing world is the close collaboration between the oncologist and the pathologist in this new era of precision and personalized medicine.

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Section: Promoting Cancer Clinical Trials In Ssamentioning

confidence: 99%

Section: Promoting Cancer Clinical Trials In Ssamentioning

confidence: 99%

Promoting Best Practice in Cancer Care in Sub Saharan Africa

Sharma

Sayed²,

Saleh³

2022

Front. Med.

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“…The National Cancer Research Institute (NCRI) Pathology Group, formerly the Cellular Molecular Pathology Initiative (CMPath), through a project called SPIRIT‐Path, developed an extension to the original SPIRIT statement describing how to effectively incorporate pathology support into clinical trial protocols. A systematic review of existing guidance for pathology items in clinical trials [ 3 ] was used to conduct an international Delphi process from which the SPIRIT‐Path guidelines were derived [ 4 ]. The checklist includes 14 items, seven elaborations and seven extensions, to the SPIRIT 2013 Statement that should be addressed in trial protocols with pathology elements.…”

Section: Introductionmentioning

confidence: 99%

“…The checklist includes 14 items, seven elaborations and seven extensions, to the SPIRIT 2013 Statement that should be addressed in trial protocols with pathology elements. SPIRIT‐Path recommends that clinical trial protocols should document the personnel, processes, and standards for all cellular and molecular pathology components of a trial, including all stages of the specimen pathway, with specific consideration of how to maximise the value of trial data and associated biological samples for further translational studies [ 4 ].…”

Section: Introductionmentioning

confidence: 99%

“…This study assessed baseline compliance with the SPIRIT‐Path guidelines [ 4 ]; first, to identify pathology items that are consistently overlooked in clinical trial protocols; second, to highlight areas of good practice and provide verbatim examples abstracted from publicly available trial protocols to illustrate how compliance can be achieved.…”

Section: Introductionmentioning

confidence: 99%

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Assessment of clinical trial protocols for pathology content using the SPIRIT‐Path guidelines highlights areas for improvement

Robinson

Bacon

Lim

et al. 2022

The Journal of Pathology CR

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The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 Statement provides evidence-based recommendations for the minimum content of clinical trial protocols. The Cellular Molecular Pathology Initiative, hosted by the UK National Cancer Research Institute, developed an extension, SPIRIT-Path, describing how to effectively incorporate pathology support into clinical trial protocols. The current study assessed the inclusion of SPIRIT-Path items in protocols of active clinical trials. Publicly available clinical trial protocols were identified for assessment against the new guidelines using a single UK hospital as the 'test site'. One hundred and ninety interventional clinical trials were identified as receiving support from the pathology department. However, only 38 had publicly available full trial protocols (20%) and following application of the inclusion/exclusion criteria, 19 were assessed against the SPIRIT-Path guidelines. The reviewed clinical trial protocols showed some areas of compliance and highlighted other items that were inadequately described. The latter lacked information about the individuals responsible for the pathology content of the trial protocol, how pathology activities and roles were organised in the trial, where the laboratory work would be carried out, and the accreditation status of the laboratory. Only one trial had information specific to digital pathology, a technology certain to become more prevalent in the future. Adoption of the SPIRIT-Path checklist will facilitate comprehensive trial protocols that address all the key cellular and molecular pathology aspects of interventional clinical trials. This study highlights once again the lack of public availability of trial protocols. Full trial protocols should be available for scrutiny by the scientific community and the public who participate in the studies, increasing the transparency of clinical trial activity and improving quality.

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Closing the loop – the role of pathologists in digital and computational pathology research

Rau,

Cross,

Lastra

et al. 2024

The Journal of Pathology CR

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An increasing number of manuscripts related to digital and computational pathology are being submitted to The Journal of Pathology: Clinical Research as part of the continuous evolution from digital imaging and algorithm‐based digital pathology to computational pathology and artificial intelligence. However, despite these technological advances, tissue analysis still relies heavily on pathologists' annotations. There are three crucial elements to the pathologist's role during annotation tasks: granularity, time constraints, and responsibility for the interpretation of computational results. Granularity involves detailed annotations, including case level, regional, and cellular features; and integration of attributions from different sources. Time constraints due to pathologist shortages have led to the development of techniques to expedite annotation tasks from cell‐level attributions up to so‐called unsupervised learning. The impact of pathologists may seem diminished, but their role is crucial in providing ground truth and connecting pathological knowledge generation with computational advancements. Measures to display results back to pathologists and reflections about correctly applied diagnostic criteria are mandatory to maintain fidelity during human–machine interactions. Collaboration and iterative processes, such as human‐in‐the‐loop machine learning are key for continuous improvement, ensuring the pathologist's involvement in evaluating computational results and closing the loop for clinical applicability. The journal is interested particularly in the clinical diagnostic application of computational pathology and invites submissions that address the issues raised in this editorial.

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

Cited by 18 publications

References 32 publications

Promoting Best Practice in Cancer Care in Sub Saharan Africa

Promoting Best Practice in Cancer Care in Sub Saharan Africa

Assessment of clinical trial protocols for pathology content using the SPIRIT‐Path guidelines highlights areas for improvement

Closing the loop – the role of pathologists in digital and computational pathology research

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