The SPIRIT-Path guidelines for the inclusion of pathology in clinical trial protocols have been published in The Lancet Oncology.
Prof Anna DeFazio, Chair TR-ANZGOG Steering Committee
The SPIRIT-Path extension guidelines were developed by international consensus, led by the National Cancer Research Institute (NCRI), to address the unpredictability in how pathology is planned and delivered in clinical trials.
Professor Anna DeFazio, Chair TR-ANZGOG Steering Committee, summarises the publication and what it means for Australian clinical trials.
“We have seen a rapid increase in reliance on tumour tissue samples for pathological assessment to confirm the diagnosis and precision molecular assessment approaches in clinical trial design. However, until now, there has been little guidance on essential documentation required for molecular pathology in clinical trials protocols.
Through TR-ANZGOG we have begun to provide standardised documentation and protocols for biospecimen collection and handling for ANZGOG trials, so it is pleasing to see the publication of guidelines recommending items that should be addressed in trial protocols with a molecular pathology component. It is particularly reassuring to see recommendations on obtaining enduring consent for future translational studies, including explicit consent for studies involving genetic testing and digital pathology images.
The new SPIRIT-Path extension guidelines address cellular and molecular pathology aspects of clinical trials, ensuring that adequate documentation and biospecimen quality assurance are incorporated into the clinical trial design from the outset. This will help to achieve successful outcomes from the laboratory components of clinical trials and to fully leverage the value of biospecimens for translational research.”
Prof Anna DeFazio, Chair TR-ANZGOG Steering Committee
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