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“If you want to exclude a pregnant woman from research, all you’ve got to do is check the box; she’s excluded, no explanation needed,” Lyerly said. “If you want to include her, there’s a whole slew of paperwork and decisions, and you have to justify your decision.”

Taking women out of the vulnerable category is a long way from changing their access to drug trials or changing the incentives drug companies have to include them, but advocates say it’s a long-overdue start. Last year, the U.S. Food and Drug Administration also released draft guidance on when to include women in clinical trials, laying out the case that there is a “critical public health need” for more information on how to use drugs safely in pregnant women.

“If you don’t do these studies, then you don’t have the data to base your decision, but you’re still making decisions,” Spong said. “You’re providing care in the absence of data.”…

…continue reading ‘Long Overlooked By Science, Pregnancy Is Finally Getting the Attention it Deserves’

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