New CONSORT & SPIRIT 2025 Guidelines Published

09 Jun 2025

Our methodology experts have contributed to the newly updated CONSORT and SPIRIT guidelines, which outline the content that should be included in reports of clinical trials and clinical trial protocols. These are essential tools for improving the transparency and quality of clinical trials. The updated guidelines were published in April in the BMJ.

Some important changes in these updated guidelines include:

Greater harmonisation between CONSORT and SPIRIT

Integration of extensions on harms, outcomes, and non-pharmacological treatments

Stronger focus on open science, including access to protocols, data, and analysis plans

Enhanced guidance on reporting harms and missing data

Sally Hopewell (Oxford) led the CONSORT revision, and An-Wen Chan (Toronto) led the SPIRIT revision. Ian White and Brennan Kahan from our methodology team were part of the international expert panel that helped to finalise the guidelines.

Ian White, Professor of Statistical Methods for Medicine said "It was very interesting being on this panel and having to decide whether each item was essential. I was especially pleased with the improved guidelines around missing data, which draw on our previous work developing guidelines to reduce, handle and report missing data in palliative care trials (link).

Brennan Kahan, Principal Research Fellow said " I was very pleased to see so much of the Unit’s work recognised in the guidelines, including around missing data, sensitivity analyses, covariate adjustment, and estimands. These guidelines represent a big step forward in making clinical trials more transparent and relevant to end-users.”

These new guidelines will be relevant to many people working in clinical trials. The updated guidelines can be found here: