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Pregnant women in clinical trials: FDA questions how to include them


Pregnant women are rarely included in clinical drug trials, creating a significant and potentially dangerous gap in knowledge. Now, a new draft guidance from the Food and Drug Administration broadens the discussion about these trials, suggesting issues to consider – including ethics and risks – when testing medications in pregnant women.

“The guidance opens the possibility of ethical conduct of trials in pregnant women but carefully lays out the caveats to be considered,” Christina Chambers, PhD, a perinatal epidemiologist at the University of California, San Diego, said in an interview. “With proper planning and thoughtful consultation with the relevant experts, this change in regulatory limitations will benefit pregnant women and their children.”

Dr. Christina D. Chambers, professor of pediatrics and director of clinical research at Rady Children's Hospital and associate director of the Clinical and Translational Research Institute at the University of California, San Diego.

Dr. Christina D. Chambers

As Dr. Chambers noted, “we have very limited pregnancy safety data for most prescription drugs” because of the lack of clinical trials and comprehensive postmarketing studies in this population.

Attitudes have evolved toward more acceptance of including pregnant women in drug trials, according to a 2015 committee opinion from the American College of Obstetricians and Gynecologists. Still, “concerns about the potential for pregnancy in research trial participants have led to practices involving overly burdensome contraception requirements,” the opinion states. “Although changes have been made to encourage and recruit more women into research studies, a gap still exists in the available data on health and disease in women, including those who are pregnant” (Obstet Gynecol 2015;126:e100-7).

The draft guidance, released April 6 by the FDA, is “intended to advance scientific research in pregnant women, and discusses issues that should be considered within the framework of human subject protection regulations,” according to posting comments in the Federal Register.

The draft notes that in some cases, the lack of data about drugs may harm pregnant women and their fetuses by leading physicians to be fearful about prescribing medication. Conversely, physicians and pregnant women are often in the dark about the risks and benefits of medications that are prescribed and used, according to the draft.

In terms of research going forward, the guidance says “development of accessible treatment options for the pregnant population is a significant public health issue.”


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