FDA Hones In On Critical Issues With Recruitment, Inclusion of Women in Clinical Trials

Regulatory NewsRegulatory News | 16 May 2018 |  By 

The US Food and Drug Administration (FDA) is looking to break down barriers hindering the availability of clinical trial data on women by focusing on two critical issues—enrollment and new products designed for treating conditions that are gender-unique.
FDA Commissioner Scott Gottlieb highlighted some of the actions the agency is pursuing as part of the two-pronged approach during a Wednesday debate hosted by FDA’s Office of Women’s Health (OWH), noting that the “years of neglect of these issues, and at times ignorance of them, have left us with disparities when it comes to the delivery of healthcare.”
There has been some progress on this front already. For example, 52% of human study subjects in late stage clinical trials in 2015 were women—up from 39% in 2000, Gottlieb said.
OWH has provided more than $40 million in research funding for 371 projects to inform FDA’s work on issues specific to women’s health and gender differences since its 1994 creation, he added. This research is critical in FDA’s understanding of the conditions that disproportionately affect women and whether some drugs have gender-specific effects.
However, there are still several areas of improvements to be address with new policies and initiatives.
Other steps FDA is taking to push for inclusion of women in trials, nationally and internationally, involve the recently launched Diverse Women in Clinical Trials Initiative. Also, FDA is investing in predictive modeling and linking health records on mothers and their babies via a multi-site research collaboration called the Medication Exposure in Pregnancy Risk Evaluation Program.
Predictive modeling offers the opportunity to study maternal exposure to drugs to anticipate response without exposure during a clinical trial, Gottlieb added.
In March, FDA also issued draft guidance on scientific and ethical considerations to aid study sponsors on the “judicious inclusion of pregnant women in clinical trials.”
“We don’t want regulatory uncertainty or lack of regulatory capacity in these areas to be a barrier to innovation and investment,” Gottlieb said.
Another step relates to the Women’s Health Technologies Strategically Coordinated Registry Network being established as part of FDA’s Medical Device Safety Action Plan—released in April—for the incorporation of data in device registries to better inform trial designs.
The registry network is intended to “provide more complete evidence in clinical areas that are unique to women, such as uterine fibroids, pelvic floor disorders, and female long-acting, reversible contraception and sterilization,” according to FDA.
The debate was focused on participation in cardiovascular clinical trials as this at least one area of clinical research in which there is under-enrollment of women, despite these types of conditions being relatively prevalent among women.
Further, cardiovascular disease has surpassed breast cancer as the leading cause of death among women, according to Gottlieb.
A new analysis on clinical studies of cardiovascular medications—conducted by FDA officials and published in the Journal of the American College of Cardiology last week—found that while women were “well represented in trials of drugs for hypertension and atrial fibrillation, and overrepresented for pulmonary arterial hypertension,” representation significantly dropped for trials of heart failure, coronary artery disease and acute coronary syndrome.
“Minimal gender differences in drug efficacy and safety profiles were observed,” the study authors added. “Given differences in pathophysiology, clinical presentation, and outcomes of cardiovascular disease in men and women, adequate participation of women is important to allow examination of possible gender differences in treatment response.”


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