SPIRIT 2025 statement: updated guideline for protocols of randomized trials

The SPIRIT 2025 statement updates the original 2013 guidelines to improve the completeness of randomized trial protocols. Through systematic review, expert input, and consensus, the checklist was refined to 34 key items, including new sections on open science and patient involvement. The updated guidelines aim to enhance transparency and protocol quality across clinical research.

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Recommended on behalf of EASE by Silvia Maina, Italy

Written by: Chan AW, Boutron I, Hopewell S, et al.

Nat Med. 2025 Jun;31(6):1784-1792. doi: 10.1038/s41591-025-03668-w