By Rose Blackburne, M.D., M.B.A.
Vice President and Global Head of General Medicine and Women's Health
Thermo Fisher Scientific
In recent weeks, the White House has pledged to invest $100 million for women's health research — a commendable step toward addressing long-standing disparities in medical research. This funding marks the first tangible commitment from the Biden administration’s national women's health research initiative introduced in November 2023.
The new investment is part of federal efforts to close gender gaps in clinical research. Despite comprising half of the U.S. and global populations, women have historically been underrepresented in research, and medical conditions that disproportionately affect women have been understudied and underfunded. Until now, studies investigating diseases exclusive to women were particularly rare and generally focused on gynecological or female-specific disorders. Even today, research on conditions other than cancer that affect women’s health accounts for a smaller portion of total clinical development investments.
Consider autoimmune diseases—an area where women bear a disproportionate burden. With nearly 80% of patients with an autoimmune disease being women, the establishment of the Office of Autoimmune Disease Research (OADR) as part of the NIH Office of Research on Women’s Health is a welcome step in the right direction. By shining a spotlight on these conditions, we can hope to improve treatment outcomes and quality of life for millions.
However, challenges persist on the road to inclusivity in clinical trials. Unique recruitment and retention hurdles for women underscore the need for tailored solutions. Flexibility in trial design and protocols, informed by the voices of female participants, is essential to ensuring the relevance and effectiveness of research outcomes.
There is a growing recognition that clinical trials should be more accessible to women to increase their participation across different therapeutic areas. Solutions such as leveraging digital and decentralized tools, implementing televisits or home health visits, scheduling flexible hours for appointments (including evenings and weekends), and providing onsite daycare facilities or playrooms and ample parking could help make clinical trials more accessible.
Beyond logistical barriers, there are broader societal and ethical considerations at play. Pregnant and lactating individuals have historically been excluded from clinical trials—a glaring omission that must be addressed. By dismantling these barriers and making trials more accessible, we can foster a more equitable landscape for medical research.
The PPD clinical research business of Thermo Fisher Scientific has long prioritized a focus on supporting women’s health studies. Through targeted recruitment strategies and a commitment to diversity, we're working to ensure that women from all backgrounds have a seat at the table in shaping the future of healthcare.
The investment in women's health research by the White House is a welcome step forward. But it's only the beginning. Let's seize this momentum to drive meaningful change and ensure that women's health remains a top priority on the national agenda. After all, the health of our nation depends on it.
Dr. Rose Blackburne is board certified in obstetrics and gynecology with over 25 years of experience in healthcare. She was a practicing physician and principal investigator for clinical trials prior to her career in the CRO industry. Dr. Blackburne has 18+ years of clinical research and development experience and has held numerous CRO global leadership positions.