Guidelines for cellular and molecular pathology content in clinical trial protocols: the SPIRIT-Path extension

Area of Science:

• Clinical Trials
• Pathology
• Biomedical Research

Background:

• Clinical trial protocols increasingly incorporate biospecimen assessment and molecular approaches.
• Standardized reporting for cellular and molecular pathology in trials has been lacking.
• Precision molecular diagnostics are crucial for trial eligibility and outcome evaluation.

Framework:

• The SPIRIT-Path extension provides international consensus guidelines for pathology content in clinical trial protocols.
• Developed using an international Delphi process and expert consensus meeting.
• Builds upon the existing SPIRIT 2013 Statement.

Implementation:

• Recommends 14 additional items (7 checklist extensions, 7 elaborations) for trial protocols with pathology components.
• Requires documentation of individuals, processes, and standards for all pathology elements.
• Includes specimen pathway management and digital pathology methods.

Implications:

• Enhances the quality and consistency of pathology data in clinical trials.
• Facilitates robust biospecimen assessment and translational studies.
• Improves the value of trial data and biological tissues for future research.