Chapter 83 - Obstacles for enrollment of women in clinical trials

Abstract

The underrepresentation of women in clinical trials (CTs) historically started with pharmacological disasters in pregnant women in the 1960s. The situation improved since regulations were put into place in 1993 in the United States, but women are still underrepresented, especially in cardiovascular studies. Reasons for this underrepresentation are in part directly correlated to the female sex, whereas others stem from a long history of research predominantly based on men. CT in electrophysiology (EP) are no exception, firstly, because some arrhythmias develop later in life in women and, secondly, because EP relies on invasive measures such as device implantations and ablation procedures, for which women are less often referred and less likely to take part in related CT. Improving patients' and physicians' education and recruitment strategies and adapting peer-reviewed journals' requirements are prerequisites to bolster women's enrollment in CT and achieve a participation-to-prevalence ratio close to 1.