Sex as a biological variable: a contemporary perspective

Abstract

Background

Incorporating sex as a biological variable (SABV) in biomedical research is essential to enhancing the translational relevance of scientific findings and ensuring equitable healthcare for both sexes. Despite policy advancements, disparities persist in the integration of SABV across research domains, particularly in cardiovascular disease, where presentation and treatment responses vary by sex.

Methods

This review synthesizes current literature and policy frameworks, including the NIH SABV mandate, to evaluate progress in SABV implementation. It also examines the roles of key stakeholders—funding agencies, publishers, and the pharmaceutical industry—in promoting or hindering SABV integration in preclinical and clinical research.

Results

Analysis reveals variable adherence to SABV policies, with persistent gaps in both study design and reporting. Case studies in cardiovascular research illustrate the consequences of SABV neglect, such as misdiagnosis and suboptimal treatment strategies. Positive shifts are observed in areas with strong policy enforcement and targeted funding incentives.

Conclusions

Effective integration of SABV is critical for scientific rigor and healthcare equity. Strategies such as mandatory researcher training, policy accountability measures, and increased sex-disaggregated data reporting are needed. Emphasizing SABV in clinical trial design and analysis will help foster a more inclusive research environment and improve health outcomes for all.

Trial Registration

Not applicable.