Industry experts are calling for a paradigm shift in how pharmaceutical companies approach women's inclusion in clinical trials, emphasizing that proactive measures rather than regulatory compliance should drive diversity efforts.
In a recent discussion hosted by BioSpace, Martin Hodosi, partner at Kearney, and Melissa Laitner, director of strategic initiatives at the National Academy of Medicine, addressed the persistent underrepresentation of women in medical research despite progress in recent decades.
"The industry mindset has evolved from being protectionist to inclusion-focused," noted Hodosi during the conversation with Lori Ellis, BioSpace's head of insights. "However, significant challenges remain in achieving appropriate gender representation across therapeutic areas."
Historical Context and Current Challenges
The exclusion of women from clinical trials has deep historical roots. Following the thalidomide tragedy in the 1950s and 1960s, which caused severe birth defects, regulatory bodies implemented protective measures that often resulted in the wholesale exclusion of women of childbearing potential from early-phase clinical research.
While regulations have evolved significantly since the NIH Revitalization Act of 1993 mandated the inclusion of women in NIH-funded research, experts point out that implementation remains inconsistent across therapeutic areas and trial phases.
"We've moved beyond simply asking if women are included to examining whether they're included in sufficient numbers to draw meaningful conclusions about safety and efficacy," explained Laitner. "The question now is whether we're capturing sex-specific differences in drug metabolism, side effect profiles, and treatment outcomes."
Industry-Led Solutions
Rather than waiting for additional regulatory guidance, the experts emphasized that pharmaceutical companies should take the initiative to improve trial accessibility and inclusivity.
"There's a mutual benefit in faster enrollment and more diverse participation," Hodosi pointed out. "Companies that design trials with inclusivity in mind from the beginning often see improved recruitment timelines and more robust data that better reflects real-world patient populations."
Practical approaches discussed included:
- Implementing flexible study visit schedules to accommodate caregiving responsibilities
- Providing transportation and childcare support for participants
- Using decentralized trial models to reduce travel burden
- Engaging women's health advocates early in protocol design
- Developing targeted recruitment strategies for underrepresented populations
Balancing Protection and Inclusion
The experts acknowledged the legitimate safety concerns that initially drove women's exclusion from certain trials, particularly for pregnant women and those who may become pregnant during a study.
"The challenge is finding the right balance between protection and inclusion," said Laitner. "We need to move away from blanket exclusions toward more nuanced approaches that assess risk appropriately while maximizing opportunities for women to benefit from clinical research."
This balanced approach requires thoughtful protocol design that includes:
- Clear pregnancy testing protocols
- Appropriate contraception requirements when justified
- Transparent communication about known and unknown risks
- Mechanisms to safely transition pregnant participants to alternative treatments when necessary
Data Analysis and Reporting
Beyond recruitment, the experts emphasized the importance of sex-disaggregated data analysis and reporting.
"Including women in trials is only the first step," Hodosi explained. "We need to analyze data by sex and report those findings transparently, even when no differences are found. This builds our collective understanding of how treatments affect different populations."
The discussion highlighted that such analyses often reveal clinically significant differences in dosing requirements, side effect profiles, and treatment outcomes that might otherwise be missed in combined analyses.
As the industry continues to evolve, the experts concluded that addressing women's underrepresentation requires commitment from multiple stakeholders, including sponsors, regulators, investigators, and patient advocates working collaboratively toward more inclusive and scientifically rigorous clinical research.
