Complete reporting of clinical trials requires more than journal articles

First published in 1996, CONSORT (Consolidated Standards of Reporting Trials) emphasised the importance of accurate and complete reporting of randomised clinical trials.1 Journal articles were the only public records of many randomised clinical trials, and the CONSORT reporting guidelines described the minimum information those articles should include. Most recommendations focused on methods and results. At the time, articles were published on paper and supplements were limited. Infrastructure to register clinical trials and to share other artefacts (eg, data, code) had not been invented. The first CONSORT update in 2001 described trial registration as desirable, but not essential.2 When a CONSORT update in 2010 added trial registration as a checklist item,3 opportunities for sharing data and code were still relatively new.4 SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, the first reporting guidelines for trial protocols, introduced recommendations about data and code sharing.5

CONSORT 2025 (doi:10.1136/bmj-2024-081123) and the soon-to-be published SPIRIT 2025 (doi:10.1136/bmj-2024-081477) update and replace previous versions of these essential reporting guidelines.67 These updates are the first since guidance for statistical analysis plans was published in 20178 and the first since data and code sharing became relatively commonplace. Updating both guidelines in tandem has led to helpful clarifications and harmonisation. The updated guidelines also include some new items. An especially welcome section on “Open science” recommends reporting whether other research artefacts are publicly available. This new section highlights an important shift from focusing on journal articles towards a contemporary understanding of …