By Diagnostics World News Staff
November 11, 2025 | Even though roughly two-thirds of pivotal studies leading to FDA drug approvals now enroll women at rates aligned with their disease burden, their inclusion has “plateaued,” according to Sophie Zaaijer, Ph.D., clinical and translational scientist at the University California Irvine and Riverside.
“We are stuck in diagnosis,” Zaaijer says. “We are stuck treating women as if they are mini men.”
Despite an edict released in 1993 to include women in trials, diagnostic criteria and disease models remain largely male-centered because they don’t take into account of the biological and hormonal rhythms that shape women’s health across their lives. That diagnostic blind spot reverberates throughout drug development.
Michael Liebman, Ph.D., managing director at digital healthcare modeling and analytics company IPQ Analytics, claims that nearly 90% of drug failures are rooted in how they are defined in terms of diagnosis and the disease state of the participants. “We are searching for our keys under a lamppost, but not beyond that beam,” he says.
Current diagnostics capture snapshots instead of trajectories of diseases, which causes misclassification of conditions that behave differently in women. The consequences extend from misdiagnosis to poor trial design and ultimately lead to ineffective therapies. Hormonal fluctuations, as previously mentioned, are also not considered, further complicating interpretation. Inflammation, metabolism, and immune activity can shift dramatically depending on menstrual phase, pregnancy, or menopause.
Zaaijer and her colleagues argue that the solution lies in dynamic, longitudinal diagnostics, such as tools that track an individual’s condition over time rather than in single moments. Digital technologies, including wearables and eDiaries, can now monitor hormonal and metabolic fluctuations in real time, providing context-rich data that reveal how women’s bodies respond to therapies.
Precision medicine platforms like Tempus and Natera are also bringing genomic biomarkers into diagnostic frameworks, offering a new lens on female-specific risks and disease resilience. The FDA’s 2019 “enrichment guidance” also encourages and offers guidance for opportunities that allow studies to enrich for “time-specific measurement points such as hormonal changes when assessing whether treatments work for women,” according to Zaaijer.