By Clinical Research News Staff 

December 17, 2025 | Progress toward equitable representation of women in clinical research—formally recognized only in 1993 when the FDA directed sponsors to include women in clinical trials—has stalled, and recent federal actions may be widening long-standing scientific blind spots. According to Nisha Perez, ScD, MS, MSPM, head of drug metabolism, pharmacokinetics, toxicology, and clinical pharmacology at HotSpot Therapeutics, the consequences reverberate through decades of drug approvals, safety failures, and missed opportunities for understanding biological differences critical to therapeutic innovation. 

Perez argues that women’s health research has been systematically deprioritized across the research ecosystem. HotSpot’s IRF5 inhibitor program for autoimmune diseases, including lupus—a condition affecting women at roughly four times the rate of men—is one example of how disease biology demands sex-specific research. She will be highlighting five incidents where sponsors failed to collect or analyze adequate female-specific data at the inaugural Health Executive & Research Summit (HERS) in San Diego next March. 

Historically, research pipelines were built on male-only foundations. In preclinical development, researchers routinely excluded female animals, even in diseases where the majority of patients are women. Perez recalls instances in which investigators had to be reminded—sometimes literally shown—how to identify female reproductive anatomy in animal models. While late-stage toxicology requirements mandate studying both sexes, earlier phases remain inconsistently inclusive. 

Clinical research has mirrored the same imbalance. For example, Ambien, approved in 1992, was studied predominantly in men. It wasn’t until two decades later until the FDA revise recommended doses for women. Similarly, digoxin, which has been used to treat heart conditions for two centuries, did not have dosage amounts adjusted until after post-hoc analyses revealed women experienced a 20% higher mortality risk in the 2000s. 

Other failures resulted in catastrophic events. Thalidomide’s birth-defect crisis led to the modern three-phase trial structure, but Perez notes it did little to ensure drugs were adequately evaluated in women afterwards. Additionally, understanding drugs in the context of pregnant women and their effects on children are still underfunded. Safety data for pregnant women is so limited that many are advised to avoid nearly all medications. This gap can be addressed with advanced AI-based modeling to predict embryo-fetal risks. 

Funding for women’s health has declined as a proportion of the NIH budget. Meanwhile, conditions such as endometriosis—understudied, difficult to diagnose, and affecting millions—remain chronically underfunded. Perez states that a strong counter movement and national push are needed in order to get back on track. 

“It’s incredibly important that industry is aware of these historical and persisting research gaps,” she says. “Drug developers and regulatory agencies alike need to recognize that women often have subtle differences in metabolism and how hormones effect their bodies. These are our wives, these are our daughters, these are our mothers—we are worth the investment.”   

To read the full story written by Deborah Borfitz, visit Bio-IT World News.