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Study Reveals Less Than 1% of U.S. Clinical Drug Trials Include Pregnant Participants
- Only 0.8% of 90,860 analyzed drug trials conducted over 15 years include pregnant participants, according to a study by researchers from Brown University published in the American Journal of Obstetrics and Gynecology.
- Around 75% of these drug trials specifically exclude pregnant women raising grave concerns over medication safety and efficacy since healthcare providers and patients must navigate medication safety without the benefit of rigorous testing in this population.
- The study's findings indicate a stubborn stagnation in rates of inclusion over the past fifteen years, despite numerous calls for increased participation in clinical studies.
- Even trials that included pregnant participants primarily focused on pregnancy-related conditions, such as labor and the prevention of preterm labor. Chronic conditions commonly affecting pregnant women and their children, like asthma and diabetes, were largely disregarded.
- Researchers underscore the urgent need for improved policies and practices to address the exclusion of pregnant women from clinical drug trials to improve the overall quality of maternal health care and foster trust between healthcare providers and patients.
- The researchers envision a future where inclusivity in clinical trials is the standard, rather than the exception, thereby empowering pregnant women with informed choices while ensuring that the medications they use are effective and safe.
- In conclusion, the persisting exclusion of a significant portion of the population, namely pregnant women, limits the applicability of medical findings and calls for immediate attention within health research communities.
- The study hopes to draw attention to the prevalence of the exclusion of pregnant women from clinical drug trials to advocate for their inclusion, ensuring the safety and well-being of both mothers and their children.
- The historical context behind these practices, the relatively recent nature of regulations requiring the inclusion of women in clinical trials and the urgency of including pregnant women in clinical trials is underscored by the researchers.
- Future medical research must address this critical issue with a culture of inclusivity to contribute to the generation of high-quality evidence that empowers pregnant women with accurate health information.
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