“Participation of Women in Clinical Trials Supporting FDA Approval of Cardiovascular Drugs.”

New Journal Article: Participation of Women in Clinical Trials Supporting FDA Approval of Cardiovascular Drugs

FDA’s Office of Women’s Health conducts studies to assess the participation of women in clinical trials in support of FDA product applications and collaborates with FDA centers and external partners to understand the impact of sex differences on response to therapy. In support of these efforts, FDA staff authored a new publication titled, “Participation of Women in Clinical Trials Supporting FDA Approval of Cardiovascular Drugs.” This study examined clinical trial inclusion/exclusion criteria, women’s participation, and the reported safety and efficacy by gender for pivotal cardiovascular disease (CVD) trials submitted to the U.S. Food and Drug Administration (FDA) supporting marketing applications over one decade (2005-2015).  Read “Participation of Women in Clinical Trials Supporting FDA Approval of Cardiovascular Drugs.” Read the editorial comment, “Participation of Women in Clinical Trials: Not Yet Time to Rest on Our Laurels.”  Learn more about FDA research on heart disease in women.