Please join Max Robinson, Deputy Director of NovoPath, on 10 November at the #NCRIfestival Virtual Event. Max will present the SPIRIT-Path Guidelines in the Cancer trials intelligence/creating better trials session.
Guidelines for the inclusion of pathology in clinical trial protocols: SPIRIT-Path
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, recently published 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.
The 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.
About the SPIRIT-Path extension
Dr Max Robinson, Deputy Director of NovoPath and Co-Chair of the NCRI’s SPIRIT-Path working group said,
‘The SPIRIT-Path extension was conceived as a means of both maximising the value of pathology content of clinical trial protocols and facilitating its execution. This guidance is the first international consensus project to formalise pathology input into clinical trials and is the necessary first step towards enabling next-generation pathology that fully meets the needs of precision medicine.’