Historical Background and Current Challenges of Female Underrepresentation in Pharmaceutical Clinical Trials

The low participation of women in clinical trials of pharmaceuticals raises ethical issues that hinder accurate assessment of the safety and effectiveness of medicines by gender. Historically, clinical trials have been conducted primarily on men, and the thalidomide scandal further excluded women from participation. Despite policies to encourage women’s participation since 1986, women’s participation in clinical trials of pharmaceuticals remains low and needs to be improved. Given the lack of research on women’s physical characteristics and hormonal changes, increasing women’s participation in clinical trials of pharmaceuticals is essential to develop safe and effective medicines and improve public health, and improvements are needed to ensure equitable health outcomes by gender.