To address the variability in the way cellular and molecular pathology are reported in clinical trial protocols, an international group of cancer researchers has published new guidelines – named “SPIRIT-Path.” The guidance 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 (1).”

Tim Kendall, Co-Chair of the National Cancer Research Institute’s SPIRIT-Path working group, said, “The SPIRIT-Path extension will 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 (2).”

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