Researchers Publish Guidance for Addressing Disease Aspects in Clinical Trial Protocols

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

The guide, which was 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 all sectors of the clinical trials community, including funders, regulators, statisticians and data managers, patient advocates, industry representatives, laboratory scientists, representatives of medical publishing and clinicians.

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

NCRI’s SPIRIT-Path Working Group Co-Chair, Dr Tim Kendall said:

“Pathology is an integral part of planning and carrying out clinical trials. To ensure methodological rigor in trials requiring pathology assessment, for trial eligibility or outcome evaluation, it is increasingly recognized that pathologists should be involved from the outset of planning and design. tests. . However, this is not always the case. “

The SPIRIT-Path extension will allow researchers to comprehensively address the cellular and molecular pathology aspects of the assay protocols, ensuring that the right skills and resources are available at the start of the assay and fully benefit from based on the value of biospecimens for translational research. “

Dr Tim Kendall, Co-Chair, SPIRIT-Path Working Group, National Cancer Research Institute

NCRI SPIRIT-Path Working Group Co-Chair Dr Max Robinson said:

“The SPIRIT-Path extension was designed as a way to both maximize the value of the pathological content of clinical trial protocols and facilitate its execution. This guide is the first international consensus project to formalize the contribution of pathology to clinical trials and constitutes the necessary first step towards enabling a new generation pathology that fully meets the needs of precision medicine. “

SPIRIT-Path recommends that protocols document individuals, processes, and standards for all cellular and molecular pathology components of the assay protocol, including all steps in the sample pathway, all digital pathology methods , and with specific consideration of the value of test and tissue data for further translational studies.

The CMPath team is now embarking on a follow-up project to develop guidelines for reporting pathology-related activities to complement the SPIRIT-Path extension. They are also developing a good clinical practice training module in ‘pathology of trials’ with the intention that the completion of training by interested staff members, regardless of the nature or location of their service, will create a community of research-ready clinical trial pathologists. .


Journal reference:

Kendall, TJ, et al. (2021) Guidelines for the content of cellular and molecular pathology in clinical trial protocols: the SPIRIT-Path extension. The Lancet Oncology.

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