Finally, a plan on how to include pregnant women in clinical trials

Author: Aimee Cunningham / Source: Science News

THE FINE PRINT

Among the stark changes for a woman during pregnancy is what she sees when she opens the medicine cabinet.

The medications she wouldn’t have given a second thought to months earlier may now prompt worry and doubt. With any drug on the shelf, she may wonder: Is this medicine safe? Do I need to adjust the dose? Avoid it altogether? An expectant mom with just a cold or a headache will find drug labels suggesting she ask a health professional before use.

Turns out, those health professionals are in the same boat as their pregnant patients: There is very little, if any, information about whether many drugs are safe to give to expectant mothers. And that can lead to situations that put fear of harm to the fetus over the health of the mother.

Case in point: As a medical resident, bioethicist and obstetrician/gynecologist Anne Lyerly got a call from a friend and fellow resident working at a different hospital. The chief resident there was trying to resuscitate a dying woman who was pregnant, and instructed Lyerly’s friend to find out what drugs were safe to use. “I said, ‘you need to tell your chief resident that he needs to go save his patient’s life,’” Lyerly recalls, and not worry about possible harms from the drugs required to do so.

The widespread reluctance to provide medication to pregnant women stems from a dearth of data on treating illnesses with drugs during pregnancy.

But because pregnant women have been generally excluded from clinical trials that study drugs, there isn’t much data to be had.

Now there’s a knock on the door that has been largely closed to this research. In April, the U.S. Federal Drug Administration released a draft of guidance on when and how to include pregnant women in clinical trials for drugs and therapies. It addresses considerations such as the effect pregnancy has on the absorption of drugs, nonclinical studies that should be conducted, and appropriate data collection and safety monitoring.

The key concern with pregnant women participating in clinical trials is safety of the fetus. The terrible birth defects that resulted from the wide use of the sedative thalidomide in the 1950s and ’60s weighed heavily on the eventual decision to largely exclude pregnant women from…

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