June 15, 2026 · Lancet (London, England) · DOI: 10.1016/S0140-6736(25)00770-6

SPIRIT 2025 statement: updated guideline for protocols of randomised trials

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The authors aimed to systematically update the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) guidelines to enhance the completeness and relevance of randomized trial protocols. Through a Delphi consensus process involving 317 participants, they introduced new items, revised existing ones, and integrated recommendations from other reporting guidelines, resulting in a comprehensive checklist of 34 minimum items for trial protocols. The updated SPIRIT 2025 statement is designed to improve transparency and completeness, benefiting various stakeholders in the research community.

An-Wen Chan, Isabelle Boutron, Sally Hopewell, David Moher, Kenneth F Schulz, Gary S Collins, Ruth Tunn, Rakesh Aggarwal, Michael Berkwits, Jesse A Berlin, Nita Bhandari, Nancy J Butcher, Marion K Campbell, Runcie C W Chidebe, Diana R Elbourne, Andrew J Farmer, Dean A Fergusson, Robert M Golub, Steven N Goodman, Tammy C Hoffmann, John P A Ioannidis, Brennan C Kahan, Rachel L Knowles, Sarah E Lamb, Steff Lewis, Elizabeth Loder, Martin Offringa, Philippe Ravaud, Dawn P Richards, Frank W Rockhold, David L Schriger, Nandi L Siegfried, Sophie Staniszewska, Rod S Taylor, Lehana Thabane, David J Torgerson, Sunita Vohra, Ian R White, Asbjørn Hróbjartsson

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Jun 24, 2026 · The New England journal of medicine

Dr. Jennifer Thompson

Portland, OR

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SPIRIT 2025 statement: updated guideline for protocols of randomised trials

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