In many countries, including the United States, most countries in Europe, Mexico, Brazil, Argentina, Russia and Canada, the female subgroup represents the majority of the population. In addition, this subgroup plays a role of paramount importance in human reproduction and a disproportionate role in healthcare. Females of all ages account for 57% of expenses at doctors’ offices. Women make approximately 80% of healthcare decisions for their families and are often care providers for their families. Thus, the rationale for collecting data to support evidence-based healthcare of females is compelling.
Nevertheless, legitimate historical concerns about the risk of exposing fetuses to investigational drugs have excluded women from many clinical studies. An unintended consequence has been severely limiting knowledge about the safety, efficacy and appropriate dosing of products used to treat hundreds of millions of women worldwide. This may contribute to women’s having a 1.5- to 1.7-fold greater risk of developing an adverse drug reaction.
The following white paper shares some lessons from our experience in women’s health studies to assist sponsors in increasing female participation in studies across the therapeutic spectrum.