New FDA guidelines say that clinical trial participants should know not just the risks and benefits of the study they’re enrolling in, but how those risks and benefits compare to the typical care they’d get at the doctor’s office. These recommendations, which are expected to be finalized later this year, seem reasonable enough at first glance. But, they’re likely to further hamper research in a population that’s already badly underrepresented in clinical studies: pregnant women.
Researchers already avoid conducting studies on pregnant women because of concerns about risks to the fetus. In clinical practice, this lack of research often translates into women foregoing care, since doctors know very little about how certain drugs could affect the developing fetus. Better safe than sorry, they reason.
Pregnant women’s lack of inclusion in formal studies doesn’t mean they’re not being experimented on. They are – just not in a systematic way that would help clarify how helpful or harmful medications and other interventions actually are. The average expectant woman takes three to five prescription drugs during her pregnancy, not to mention many over-the-counter herbs and supplements.
“It’s really problematic that we don’t know even the basic pharmacokinetics of how certain medications work in pregnant women,” says Miriam Kuppermann, head of the clinical research program for the University of California, San Francisco’s maternal-fetal medicine program. “There’s good reason to believe that those will be different in pregnant women because of all the pregnancy hormones.”
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