Shirin Heidari, Thomas F Babor, Joan Marsh, Bahar Mehmani, Roli Mathur
The Lancet – November 15, 2025
We welcome the revised Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2025 guidelines published in The Lancet and commend the efforts to enhance transparency and rigour in clinical trial protocols. Accurate and transparent reporting is fundamental to ensuring the validity of clinical trial findings, enhancing reproducibility and clarifying the generalisability of results across diverse populations. The updated SPIRIT guidelines introduce several important improvements, including clearer definitions of protocol contributors and strengthened guidance on data sharing and trial registration, which move us towards greater transparency and accountability in clinical research. However, we note with concern the continued absence of specific recommendations regarding sex and gender considerations, including how these intersect with other variables. This lack of recommendations is a crucial gap, given the persistent under-representation of women in clinical trials and the growing body of evidence about the risks of gender bias in trial design and reporting.