FDA Issues Draft Guidance on Pregnant Women in Clinical Trials

Megan Brooks

April 13, 2018

The US Food and Drug Administration (FDA) has issued draft guidance for industry outlining the scientific and ethical issues that should be addressed when considering the inclusion of pregnant women in clinical trials of drugs and biological products.

There are more than 60 million women of reproductive age in the United States and nearly 4 million births each year, according to US National Vital Statistics data.

"This draft guidance is intended to advance scientific research in pregnant women, and discusses issues that should be considered within the framework of human subject protection regulations," the FDA says. The guidance document discusses how and when to include pregnant women in drug trials based on the FDA's current thinking on this subject, they note.

The draft guidance "supports an informed and balanced approach to gathering data on the use of drugs and biological products during pregnancy through judicious inclusion of pregnant women in clinical trials and careful attention to potential fetal risk," they say.

It is intended to serve as a focus for ongoing discussions among the FDA, drug companies, the research community, institutional review boards, and other parties involved with the conduct of clinical trials in pregnant women.

"From a scientific and ethical standpoint, the population of pregnant women is complex based on the interdependency of maternal and fetal well-being, and the need to take into consideration the risks and benefits of drug therapy to both woman and fetus," the FDA notes. The issues discussed in the draft guidance apply to both clinical trials that enroll pregnant women and clinical trials that allow enrolled subjects who become pregnant to remain in the trial.

Some of the information in the guidance applies to drugs indicated to treat pregnancy-specific conditions such as preterm labor and preeclampsia, but the larger focus is on drugs indicated for conditions that often occur in young women of reproductive age, the FDA explains.

There are multiple reasons for considering the inclusion of pregnant women in clinical trials, they note. Women need safe and effective treatment during pregnancy, and failure to establish the dose/dosing regimen, safety, and efficacy of treatments during pregnancy may compromise the health of women and their fetuses, they point out. In some settings, enrolling pregnant women in clinical trials may offer the possibility of direct benefit to the woman and/or fetus that is unavailable outside the research setting. Developing accessible treatment options for the pregnant population is a "significant public health issue," the agency says.

Because of the complex ethical issues involved in designing a clinical trial that includes pregnant women, the FDA advises sponsors to consider including an ethicist in planning the drug development program and consider meeting with the appropriate FDA review division early on to discuss when and how to include pregnant women in the drug development plan. These discussions should involve FDA experts in bioethics and maternal health, the FDA says.

Comments and suggestions regarding this draft guidance document may be submitted until June 8, 2018, through the Federal Register.

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