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

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

 Integrating sex-gender considerations into clinical trials facilitates analysis of biological and social variables and gender-sensitive methodologies that support scientific rigor, lead to clinical relevance, and protect vulnerable participants. 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 has been the gender integration technical partner to the Bill & Melinda Gates Foundation since the formation of the foundation’s Gender Equality team. Through this relationship, the GCfGE provides direct technical assistance to foundation teams and individuals to support them to apply a gender lens to their work and to provide concrete, evidence-based recommendations to accelerate sector and gender equality outcomes through effective gender integration. Through this partnership, 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.