All Inclusive: Tips For Involving More Women in Clinical Trials
With substantial disparities continuing to exist in the prevention, treatment and clinical outcomes of cardiovascular disease in women, a recent guest editor’s page in the Journal of the American College of Cardiology stresses the need for clinical scientists to have additional sex-specific strategies and methods at their disposal to study sex-specific cardiovascular health and disease in women.
“Under-representation of women in cardiovascular clinical trials and data registries, coupled with lack of sex-specific data analysis, has constrained the evidence base for clinical decision-making,” write Nanette K. Wenger, MD, FACC, Pamela Ouyang, MBBS, Virginia Miller, PhD, and C. Noel Bairey Merz, MD, FACC. They note that clinical investigations addressing cardiovascular disease often fail to consider factors like reproductive history and psychosocial variables that disproportionately affect women.
Their advice to investigators:
- Improve trial design, enrollment and retention of women subjects
- Improve results analysis and reporting
- Provide better incentives to perform research in women
- Mandate changes in the drug and device development and approval processes
- Incorporate specific recommendations for women into guidelines when data are sufficient
- Apply proven sex-based differences in risk stratification, diagnostic testing and drug usage and dosing
They also suggest that population researchers consider including additional relevant clinical information such as hormonal phenotype, hormonal level status, pregnancy-related disorders, depression, abuse, domestic violence and post-traumatic stress disorders, as part of demographic information collected from study participants.
“Including this information in appropriate databases will expand the scientific understanding of sex differences in clinical cardiovascular disease and provide additional evidence of specific sex-related variables influencing cardioascular disease in women,” they write.
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