Guidelines for cellular and molecular pathology content in clinical trial protocols: the SPIRIT-Path extension update and remapping 2026

clinical trial protocols

The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) Statement provides evidence-based guidance for transparent and comprehensive reporting of clinical trial protocols. The SPIRIT-Path extension, published in 2021, addresses cellular and molecular pathology-related content within trial protocols. Following the publication of the updated SPIRIT Statement in 2025, revision and remapping of SPIRIT-Path is required to ensure alignment with SPIRIT 2025 and to incorporate contemporary clinical trial methodology, including emerging areas such as digital pathology and artificial intelligence. Registered: 26 October 2026

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Contact: Tim Kendall Email: [email protected]