Integrating Sex-Gender for Informative Clinical Trials: Points to Consider

Design, Analyze and Communicate: Working together to improve clinical study outcomes.

 Integrating Sex-Gender for Informative Clinical Trials: Points to Consider

To run relevant and rigorous clinical trial and protect vulnerable participants, it is important to integrate sex-gender considerations into study design, analysis, and communication. This overview of best practices includes links to tools and references to support sex-gender integration into clinical trials.

About The Global Center for Gender Equality at Stanford University

The Global Center for Gender Equality (GCfGE) at Stanford University’s School of Medicine works to translate gender data, research, analysis and theory into evidence-based, practical applications for partners in the development space.

The GCfGE team is the gender integration technical partner to the Gates Foundation. Through this relationship, the GCfGE developed the guidance Integrating Sex-Gender for Informative Clinical Trials: Points to Consider, and provided recommendations to the DAC Best Practices guidelines.

Please note: Implementors of studies should also always refer to relevant regulatory standards and guidelines (e.g. FDA, EMA) to assist with study/protocol design.