CONSORT 2025: Changes From CONSORT 2010 and Implications for Reporting Randomised Trials

CONSORT 2025 is the updated Consolidated Standards of Reporting Trials statement, published simultaneously in PLOS Medicine, The BMJ, JAMA, The Lancet and Nature Medicine on 14 April 2025, and it supersedes CONSORT 2010 for reporting randomised trials.

Reasons for replacing CONSORT 2010

Hopewell and colleagues, writing for the SPIRIT-CONSORT executive group, describe a three-stage development process behind CONSORT 2025: a scoping review of the trial-reporting literature, a three-round Delphi survey (with 317, then 303, then 290 respondents), and a two-day expert consensus meeting held in March 20231. The explicit aim was to bring the statement in line with developments CONSORT 2010 predates — open-science expectations around registration and data sharing, a stronger expectation that harms are reported as rigorously as benefits, and growing attention to patient and public involvement in trial design.

New content in the 30-item checklist

CONSORT 2025 updates the 25-item CONSORT 2010 checklist to a 30-item checklist through additions and revisions to its structure and content1. The additions cluster around five themes: a data-sharing statement (item 4); authors' conflicts of interest (item 5b); patient and public involvement in the trial's design and conduct (item 8); eligibility of trial sites and interventionists, not just participants (item 12b); a dedicated harms-assessment item (item 15); and separate treatment of analysis populations and missing data (items 21b and 21c). A new "open science" grouping brings registration, protocol and analysis-plan access, data sharing, and funding/conflict-of-interest disclosure together under one heading, and content from the Harms, Outcomes, and Non-pharmacological Treatment extensions, plus the TIDieR intervention-reporting checklist, has been integrated directly into the core statement.

Relationship of the extensions to CONSORT 2025

The CONSORT extensions — for adaptive designs, cluster trials, crossover trials, early-phase trials, factorial trials, non-inferiority and equivalence trials, pragmatic trials, multi-arm trials, n-of-1 trials, pilot and feasibility trials, and within-person trials, among others — are not retired by CONSORT 2025. The 2025 authors state that each extension will be aligned with the new core statement over time; until that occurs, a trial that requires a specific extension should be reported using the core 30 items of CONSORT 2025 together with the current published version of that extension, rather than on the assumption that the extension has already been updated1.

Key points

Practical application

Frequently asked questions

@misc{consort_2025_updated_guideline_2026,
  author       = {{Pubrica Academy}},
  title        = {CONSORT 2025: Changes From CONSORT 2010 and Implications for Reporting Randomised Trials},
  howpublished = {Pubrica},
  year         = {2026},
  month        = {oct},
  url          = {https://pubrica.com/academy/concepts-definitions/consort-2025-updated-guideline/},
  note         = {Accessed: <span data-cite-acc="iso">2026-10-15</span>}
}

[ ] Data sharing statement present (item 4)
[ ] Authors' conflicts of interest stated (item 5b)
[ ] Patient/public involvement described (item 8)
[ ] Site and interventionist eligibility stated, not just participant eligibility (item 12b)
[ ] Harms assessed and reported with the same rigour as benefits (item 15)
[ ] Analysis populations and missing-data handling reported separately (items 21b, 21c)
[ ] Relevant CONSORT extension identified and its current version checked