Sex as an important biological variable in biomedical research

Area of Science:

• Biomedical Research
• Health Sciences
• Drug Safety

Background:

• Experimental research often uses only one sex, with results extrapolated to both without justification.
• This practice has led to significant economic losses and fatalities, particularly due to drugs posing greater health risks to women.
• Male biases in basic, preclinical, and clinical research are a primary cause of these issues.

Purpose of the Study:

• To review the reasons and methods used by funding organizations to promote the integration of sex/gender in research.
• To introduce editorial policies of prominent journals regarding sex-specific reporting.
• To highlight considerations for integrating sex as a biological variable in scientific studies.

Main Methods:

• Review of initiatives by funding bodies like the European Commission, Canadian Institutes of Health Research, and US National Institutes of Health.
• Analysis of editorial policies in prominent scientific journals concerning sex-specific reporting.
• Discussion of practical considerations for incorporating sex as a biological variable.

Main Results:

• Funding organizations are actively encouraging researchers to include sex/gender considerations across all research stages.
• Journal policies are evolving to mandate or recommend sex-specific reporting.
• Integrating sex as a biological variable requires careful planning and methodology.

Conclusions:

• Sex must be recognized as a critical biological variable in all research, from basic to clinical.
• Considering sex/gender in research design and analysis is essential for producing precise, reproducible results.
• This approach is vital for ensuring drug safety and efficacy in both males and females, preventing adverse events and economic loss.