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Medical News & Perspectives
August 28, 2018

Addressing Barriers to Inclusion of Pregnant Women in Clinical Trials

JAMA. 2018;320(8):742-744. doi:10.1001/jama.2018.9989

When psychiatrist Crystal Clark, MD, sees new patients who are pregnant, they’re usually scared. They’ve either abruptly stopped taking medication for their bipolar disorder—sometimes on the advice of another physician or even their pharmacist—and aren’t doing well, or they’re still taking their medication and are worried that it could hurt their baby.

Women with bipolar disorder are far from alone in struggling over whether to continue taking their medication when pregnant, stopping it, or switching to a different one. Those with other chronic conditions, such as asthma, depression, and epilepsy, as well as acute conditions, such as a bacterial infection, face the same dilemma. That’s because pregnant women are “drug orphans,” a subset of the population that clinical trials for the most part have excluded.