Tuesday, March 16, 2021

FDA and Duke-Margolis Host Workshop on Scientific and Ethical Considerations for Including Pregnant People in Clinical Trials - Drug Information Update

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FDA Center for Drug Evaluation and Research Division of Drug Information

FDA and Duke-Margolis Host Workshop on Scientific and Ethical Considerations for Including Pregnant People in Clinical Trials

Part of Longer-Term Effort to Bolster Knowledge about Drug Use During Pregnancy

Approximately 6 million people get pregnant every year in the United States. There are roughly 4 million live births annually. About 90% of pregnant people take a medication, including 70% who take at least one prescription medication. Medication use in pregnancy is only expected to increase, as people have babies later in life and chronic conditions like obesity and cardiovascular disease continue to grow.

But there are gaps in our knowledge about how medications affect pregnancy, the pregnant person, and the fetus, partly because pregnant people are underrepresented in clinical research. We need better representation of this population in clinical studies to try to address the knowledge gaps.

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