13 November 2025 | GENDRO and the European Association of Science Editors (EASE)
FOR IMMEDIATE RELEASE – Geneva, 13 November 2025 GENDRO and the European Association of Science Editors (EASE) welcome collaboration towards stronger, more inclusive clinical trial standards.
GENDRO and the European Association of Science Editors (EASE) welcome the opportunity to collaborate with partners leading global research reporting standards to enhance the systematic inclusion of sex and gender considerations in clinical trials.
In a correspondence published today in The Lancet, authors from GENDRO and EASE commend the latest update to the SPIRIT guidelines [SPIRIT 2025 statement: updated guideline for protocols of randomised trials, The Lancet, 17 May 2025] for strengthening transparency and completeness in clinical trial reporting.
However, they express concern that explicit attention to sex and gender remains absent. The authors invite the SPIRIT and CONSORT groups to join forces with GENDRO and EASE in developing a SAGER–SPIRIT–CONSORT guidance note, ensuring that these widely adopted frameworks for trial reporting reflect the scientific and ethical importance of integrating sex and
gender—and their intersections with other health determinants—at every stage of clinical research.
Such a guidance note could provide clearer recommendations for researchers, authors, journal editors, publishers, and other key stakeholders, who collectively share the responsibility for closing the sex and gender evidence gap and ensuring that clinical trials are inclusive.
This proposed collaboration aligns with GENDRO’s ongoing work to develop the SAGER–Ethics guidelines, which aim to embed sex and gender considerations into research ethics review processes—advancing equity, accountability, and excellence in science. The initiative complements broader efforts to harmonise standards across the global research ecosystem.
“Transparency and accountability in clinical research require that critical dimensions influencing health experiences and outcomes are systematically integrated into study design, conduct, and reporting,” said Dr Shirin Heidari, Executive Director of GENDRO and lead author of the SAGER guidelines. “Integrating sex and gender is indispensable for scientific validity, ethical integrity, and the equitable translation of research into health policy and practice. Harmonising SAGER with SPIRIT and CONSORT represents an important step towards coherent global standards.”
Developed nearly a decade ago under the auspices of the European Association of Science Editors, the SAGER guidelines were created to improve reporting practices and raise awareness of the importance of sex and gender in research. EASE and GENDRO continue to promote their implementation, which has been adopted by major publishers and leading health journals, translated into several languages, and included in the latest WHO Guidance for Best Practices for
Clinical Trials.
EASE reaffirms its commitment to improving the quality and inclusivity of scientific publishing. “EASE’s mission is to raise the global standard of scientific editing and publishing. We continue to promote the inclusion of sex and gender reporting in research publications,” said Bahar Mehmani,
President of EASE, speaking on behalf of the Association.
ENDS
For media enquiries:
GENDRO | info@gendro.org | www.gendro.org
European Association of Science Editors (EASE) | www.ease.org.uk
Further reading:
- Heidari, S., Babor, T. F., Marsh J., Mehmani B. Mathur, R. Aligning SPIRIT and SAGER guidelinesfor equity in clinical trials. (2025) The Lancet, Volume 406, Issue 10517, 2319 – 2320 https://doi.org/10.1016/S0140-6736(25)01689-7
- Heidari, S., Babor, T. F., De Castro, P., Tort, S., & Curno, M. (2016). Sex and Gender Equity in Research: rationale for the SAGER guidelines and recommended use. Research Integrity and Peer Review, 1, 2. https://doi.org/10.1186/s41073-016-0007-6 (BioMed Central)
- Heidari, S., Estevez Fernandez, D. G., Coates, A., Hosseinpoor, A. R., Asma, S., Farrar, J., & Kenney, E. M. (2024). WHO’s adoption of SAGER guidelines and GATHER: setting standards for better science with sex and gender in mind. The Lancet, 403(10423), 226–228. https://doi.org/10.1016/S0140-6736(23)02807-6 (PubMed)
- Chan, A.-W., Boutron, I., Hopewell, S., Moher, D., Schulz, K. F., Collins, G. S., et al. (2025). SPIRIT 2025 statement: updated guideline for protocols of randomised trials. The Lancet. https://doi.org/10.1016/S0140-6736(25)00770-6 (consort-spirit.org)
- World Health Organization. (2024). Guidance for best practices for clinical trials. Geneva: WHO. ISBN: 978-92-4-009771-1. (World Health Organization)
- World Economic Forum. (2025). A Prescription for Change: Closing the Gender Health Gap. (White paper). https://reports.weforum.org/docs/WEF_Prescription_for_Change_2025.pdf