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SPIRIT-Path: inclusion of pathology in clinical trial protocols:

An international group of cancer researchers, led by the National Cancer Research Institute’s (NCRI) Cellular Molecular Pathology Initiative (CMPath), has published guidance to address the variability in how pathology is planned and delivered in clinical trials.

The guidance, which has been published today in The Lancet Oncology, was produced through the development of international consensus, drawing on expertise from Africa, Asia, Australasia, Europe and North America and from all sectors of the clinical trials community including funders, regulators, statisticians and data managers, patient advocates, industry representatives, laboratory scientists, medical publishing representatives, and clinicians.

This guidance, called SPIRIT-Path, was developed as an extension to the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 Statement which provides evidence-based recommendations to address the variability in quality and content of clinical trial protocols. The SPIRIT Statement is widely endorsed by medicines developers, academia, regulators and medical journals.

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.

For more information on NCRI website click here>

HSC R&D Division is an NCRI partner