CONSORT, SPIRIT, and ICMJE All Update at Once — Your Templates Can't Keep Up

The last time the reporting-standards floor shifted this much, statisticians had two years to notice. This time the updates arrived in a cluster: CONSORT 2025 and SPIRIT 2025 were published together and jointly hosted at consort-spirit.org, while the ICMJE Recommendations were refreshed in January 2026 — quietly, with no annotated changelog on the landing page. What changed in the ICMJE update specifically requires downloading the PDF or digging through ICMJE News & Editorials; teams waiting for a press release may still be waiting.

The CONSORT and SPIRIT changes are better documented. CONSORT 2025 adds seven new checklist items, revises three, and removes one relative to CONSORT 2010. The additions that bite hardest for biometrics teams sit in a new open-science section: item 3 requires the statistical analysis plan to be publicly accessible; item 4 requires sharing of participant-level data and statistical code. Those two items are not a soft nudge toward transparency — they are checklist requirements that journals enforcing CONSORT 2025 will expect authors to address. Sponsors who treat SAP content as commercially sensitive, or whose code libraries are not designed for external release, now have a structural conflict to resolve before the manuscript stage.

SPIRIT 2025 arrives from a 317-participant Delphi process and a 30-expert consensus meeting, adding two new protocol items and a matching open-science section, along with strengthened harms-assessment requirements and a new item on patient and public involvement in trial design. The alignment between CONSORT 2025 and SPIRIT 2025 is deliberate — both are now cross-referenced with TIDieR and key CONSORT extensions, and accompanied by updated Explanation & Elaboration documents — but that alignment is with each other, not with ICH E3 or E6. Protocol teams building SAP pre-specification workflows under SPIRIT 2025 will need to reconcile its requirements with regulatory document standards that have not moved on the same timeline.

Arriving in parallel, a Journal of Clinical Epidemiology paper proposes replacing the traditional summary-statistic Table 1 with distributional graphics — “showing” covariate structure rather than “telling” it through means and medians. The critique is methodologically sound: collapsed point summaries genuinely do obscure imbalance and skewness in ways that love plots and similar diagnostics do not. But this is a methodological commentary, not a simulation study, and it carries no regulatory endorsement. Statistical programmers should be aware of it without rebuilding their ADaM-based TLF shells around it.

The practical priority list for most teams: audit SAP templates and TLF shells against CONSORT 2025’s new items, particularly items 3 and 4; review SPIRIT 2025’s open-science additions against current protocol SOP language; and — once someone has actually read the PDF — determine what the January 2026 ICMJE update changed. The third item on that list should have been done in January. The fact that it is still an open question across much of the industry is, itself, a signal worth noting.

Protocol read: The reporting-standards floor moved twice — once for journals (CONSORT/SPIRIT), once for manuscripts (ICMJE) — and biometrics teams whose templates predate the changes are now non-conformant in ways the next journal submission will surface.

What to do now:

• Audit SAP and TLF templates against CONSORT 2025 items 3 (SAP public access) and 4 (data/code sharing) before the next manuscript stage; resolve the commercial-sensitivity tension early, not during journal review.
• Read the ICMJE January 2026 PDF directly — the landing page hides what actually changed.
• Keep current Table 1 conventions until distributional-graphics alternatives carry regulatory or journal endorsement; the JCE commentary is methodologically sound but not yet policy.