Clinical research is evolving to address historical gender disparities, with a growing focus on improving women’s health through more inclusive trials. Until 1993, U.S. clinical trials were not even required to include women, a reality that has led to gaps in understanding treatment effects across genders.
While progress has been made, challenges remain, as evidenced by a recent JAMA study showing that women account for only 29% of participants in cardiovascular device clinical trials.
Ensuring diverse representation in research is crucial for developing effective treatments for all patients. Inclusive clinical trials lead to better science and, ultimately, better medicine. To achieve this, the biopharmaceutical industry is fostering collaboration among sponsors, trial sites, regulators, and patients.
Companies are reshaping trial protocols with more inclusive eligibility criteria, while trial sites are expanding their outreach to ensure broader patient demographics are represented.
Tools and resources are being developed to support patient-centered research, helping investigators understand real-world barriers such as work schedules, caregiving responsibilities, and transportation challenges. Continuous patient feedback loops allow researchers to refine trial designs, ensuring accessibility and inclusivity.
Maternal health research is also gaining traction, with experts addressing gaps in medicine safety data for pregnant and breastfeeding women. A comprehensive evaluation of regulations across 19 countries is helping to provide healthcare providers with stronger evidence for treatment decisions.
The future of clinical research is shifting toward patient-centered trials, integrating digital solutions and modern trial designs to better reflect real-world needs.
However, sustained momentum is necessary to drive progress. Through continued collaboration, the medical community can ensure that better clinical trials lead to improved healthcare outcomes for all—especially for women who have historically been underrepresented.
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