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Rethinking women’s health

The need for robust COA data to close the research gap

Despite the meaningful progress made in drug development, the gender gap in healthcare remains a serious challenge.1 Research shows that women spend 25% more of their lives in poor health than men, with less access to equitable treatment and improved outcomes. Yet many therapeutic areas that affect women remain under-researched and underrepresented in clinical development.2 Consequently in 2024, the FDA’s Office of Women’s Health released an updated Research Roadmap, with one of its priorities being the selection and incorporation of appropriate clinical outcome assessments (COAs) and endpoints in studies designed for or inclusive of women.3

A review of the availability and application of COAs within the context of the FDA’s roadmap highlighted several patterns and gaps in how women’s health is currently evaluated across therapeutic areas.

An evaluation of the ePROVIDE platform from Mapi Research Trust, which references more than 8,000 COAs, label claims and regulatory recommendations on the use of COAs, identified 527 COAs relevant to women’s health, across 254 therapeutic indications. Of these, only 47 were originally developed in an all-female population. Despite long-standing recognition of women’s unique health needs, there are a limited number of COAs specifically tailored to addressing those needs. Of the 527 COAs available for women’s health, more than half were for neoplasms. Cardiovascular disease, musculoskeletal disorders, and psychological conditions were found to have the least number of COAs available. In fact, only 12 COAs were found for cardiovascular diseases, and just one corresponding product label in this area has been approved by the FDA to date.

These findings highlight a critical challenge for sponsors: the tools used to measure meaningful outcomes in women’s health are not yet sufficiently tailored to the needs of women. While patient-reported outcomes (PROs) remain the most common COAs developed in female populations, regulatory guidance rarely specifies female-centric tools. Among 21 total guidelines referencing COAs, including six from the FDA and five from the EMA, none of the recommended COAs were developed exclusively in female populations.

As regulators and patients call for more inclusive research, there is an increasing need and ability for sponsors to drive more relevant study design and execution, particularly when it comes to choosing endpoints, capturing patient experience, and demonstrating value to regulators and patients alike.

Sponsors pursuing innovation in women’s health need more than data; they need a research partner with the scale, therapeutic knowledge, and operational excellence to deliver results.

ICON’s commitment to advancing Women’s Health research

ICON brings deep therapeutic knowledge, operational precision, and global infrastructure to support robust clinical research in women’s health. With over 184 clinical studies in women’s health, involving more than 64,700 patients and 8,200 sites worldwide, ICON has already contributed significantly to the evolving landscape of women’s health research. Our expertise span the full spectrum of women’s health, from menopause-related conditions and fertility to maternal health, sexual health, and supportive care in oncology. 

Further, ICON study teams are proficient in the design and execution of women’s health trials, which rely on complex endpoint collection, including DEXA, transvaginal ultrasound (TVU), endometrial biopsy, and PRO-based assessments. ICON also supports sponsors in navigating the regulatory and scientific considerations involved in COA selection, especially in areas where fit-for-purpose instruments are lacking or must be adapted for specific populations.

As more agencies and researchers push for equity in drug development, using fit-for-purpose COAs and partnering with organizations like ICON, which bring therapeutic knowledge, regulatory insight, and proven operational delivery to every trial, will be critical.

Learn more to work with ICON for your women’s health portfolio.

References

1 Ploszajski, A. (2024) “Women’s Health: Women's health is in crisis; Imperial experts are calling for a fairer system that works for everyone.” Imperial College London. Available at: https://www.imperial.ac.uk/stories/womens-health/

2 Whiting, K. (2024) “Women's health gap: 6 conditions that highlight gender inequality in healthcare”. World Economic Forum. Available at: https://www.weforum.org/stories/2024/10/women-health-gap-healthcare-gender/

3 Food and Drug Administration (FDA). (2015) Women's Health Research Roadmap 2015. Available at: https://www.fda.gov/consumers/about-owh-research/womens-health-research-roadmap

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